Apparatus and methods for treating obstructions within body lumens

ABSTRACT

An apparatus is provided that is operable in different modes to perform various functions for treating a body lumen. The apparatus includes a shaft including proximal and distal ends, a lumen extending therebetween, and a balloon on the distal end. The apparatus includes a valve on the distal end that selectively opens or closes an outlet communicating with the lumen. With the valve open, fluid introduced into the lumen exits the outlet into a body lumen. With the valve closed, fluid introduced into the lumen expands the balloon. The valve may be biased to be closed, e.g., by a spring element disposed within the balloon. Optionally, the apparatus also includes an actuator for expanding a helical member within the balloon interior, e.g., either before or after expanding the balloon, such that the helical member and balloon may adopt an expanded helical shape for removing material within a body lumen.

RELATED APPLICATIONS

This application claims benefit of co-pending provisional applicationSer. Nos. 61/271,627, filed Jul. 23, 2009, 61/283,035, filed Nov. 25,2009, 61/342,755, filed Apr. 19, 2010, and 61/397,854, filed Jun. 17,2010, and is a continuation-in-part of co-pending application Ser. No.12/497,135, filed Jul. 2, 2009, which claims benefit of co-pending U.S.provisional application Ser. Nos. 61/078,330, filed Jul. 3, 2008,61/153,620, filed Feb. 18, 2009, 61/214,667, filed Apr. 27, 2009, and61/215,732, filed May 8, 2009. The entire disclosures of theseapplications are expressly incorporated by reference herein.

FIELD OF THE INVENTION

The present invention relates generally to apparatus for treatingobstructive material and/or other obstructions within a body lumen of apatient, e.g., within a tubular graft, aorto-venous fistula, bloodvessel, and the like. More particularly, the present invention relatesto apparatus, e.g., balloon catheters, for infusing fluids into a bodylumen, for removing or otherwise capturing thrombus or other obstructivematerial within a body lumen, and/or for dilating a body lumen, and tomethods for making and using such apparatus.

BACKGROUND

Flow within a blood vessel or other body lumen within a patient'svasculature may become constricted or ultimately interrupted for avariety of reasons. For example, a vessel may gradually narrow due toinflammation and/or cell proliferation. In addition, thrombus may formdue to such narrowing or other flow problems within a vessel.

For example, an aorto-venous graft may be implanted in an arm of apatient experiencing kidney failure, e.g., to facilitate dialysistreatment. Such grafts may be a fistula formed directly in the patient'sbody, e.g., through tissue between an adjacent artery and vein or othervessels, may be a xenograft implanted between two vessels, or may be asynthetic graft. Such grafts only have a limited life cycle due toinflammation, thrombus formation, and the like. Once such a graftbecomes sufficiently occluded or otherwise deteriorates, a new graftmust be implanted at a new location for subsequent treatment.

Accordingly, apparatus and methods for removing material fromaorto-venous grafts, blood vessels, or other body lumens and/orotherwise treating body lumens would be useful.

SUMMARY

The present invention is directed to apparatus for treating a body lumenof a patient, e.g., a tubular graft, aorto-venous fistula, blood vessel,and the like. More particularly, the present invention is directed toapparatus for infusing fluids into a body lumen, for removing orotherwise capturing thrombus or other obstructive material within a bodylumen, and/or for dilating a body lumen, and to methods for making andusing such apparatus.

In accordance with a first embodiment, an apparatus is provided fortreating a body lumen that is operable in different modes to performvarious functions, e.g., possibly reducing the number of deviceexchanges during a procedure. For example, the apparatus may include ashaft including a proximal end, a distal end sized for introduction intoa body lumen, a lumen extending therebetween, and a balloon on thedistal end having an interior communicating with the lumen. Theapparatus may also include a valve on the distal end of the shaft thatselectively opens or closes an outlet communicating with the lumen. Withthe valve open, fluid introduced into the lumen may exit the outlet intoa body lumen beyond the distal end. With the valve closed, fluidintroduced into the lumen may expand the balloon from a contractedcondition to an expanded condition, e.g., a cylindrical shape fordilating an obstruction within a body lumen or a bulbous shape forremoving material within the body lumen. Optionally, the valve mayinclude a stop that may be extended to push a distal end of the balloon,e.g., to stretch or otherwise reduce a profile of the balloon and/orotherwise facilitate introduction into a patient's body.

In addition or alternatively, the apparatus may include an actuator foraxially compressing the balloon, and the balloon may be configured toexpand from the contracted condition to an expanded helical shape whenaxially compressed. For example, the actuator may include an innermember within the shaft that is coupled to a distal end of the balloon,and a helical member may extend around the inner member within theballoon. When the inner member is directed proximally or otherwiseactuated, the helical member may be compressed and consequently expandradially outwardly, thereby expanding the balloon to the expandedhelical shape. The inner member may be extended distally to extend andreturn the balloon back towards the contracted condition, e.g., afterusing the balloon in the expanded helical shape to remove materialwithin a body lumen.

In accordance with another embodiment, an apparatus is provided fortreating a body lumen that includes an elongate tubular outer memberincluding a proximal end, a distal end, and a first lumen extendingbetween the proximal and distal ends; an expandable balloon including aproximal end secured to the tubular member distal end, and a distal endincluding an outlet, the balloon including an interior communicatingwith the first lumen and the balloon outlet; and an elongate innermember slidably disposed within the first lumen. The elongate member mayinclude a proximal end adjacent the tubular member proximal end, and adistal end extending from the balloon outlet. The balloon and elongatemember may include cooperating features providing a valve forselectively opening and closing the balloon outlet. For example, asealing member may be provided on the distal end of the elongate membersized to be engaged with the balloon distal end to substantially sealthe outlet from fluid flow.

The elongate member may be movable between a first position wherein thesealing member is spaced apart from the balloon outlet such that fluidintroduced through the first lumen passes through the balloon interiorand out the balloon outlet, and a second position wherein the sealingmember substantially seals the balloon outlet such that fluid introducedthrough the first lumen enters the balloon interior to expand theballoon.

Optionally, the elongate member may be biased to one of the first andsecond positions, but may be selectively directed to the other of thefirst and second positions. In one embodiment, a spring element may beprovided within the balloon interior that is coupled to the elongatemember for biasing the elongate member proximally, e.g., to engage thesealing member with the outlet to substantially seal the outlet. Forexample, the spring element may be coupled between a spring stop on thedistal end of the balloon and a collar or other attachment member on theelongate member. When the elongate member is advanced distally to openthe outlet, the spring element may be compressed between the spring stopand the collar such that when the elongate member is released, thespring element may automatically direct the elongate member proximallyto reseal or enhance resealing the outlet with the sealing member.

If desired, the distal end of the balloon may include a distal tipshaped and/or configured to facilitate sealing and/or opening theoutlet. For example, in one embodiment, the sealing member may include atapered proximal end, and the distal tip may be flared outwardly awayfrom the balloon such that the tapered proximal end of the sealingmember may be seated at least partially in the flared distal tip. Suchan embodiment may increase surface contact between the sealing memberand the distal end, which may enhance sealing the outlet. In addition oralternatively, the flared distal tip may maximize the free area of theoutlet when the sealing member is directed away from the outlet.

In another embodiment, a distal tip may be provided that is resilientlyexpandable, e.g., to increase surface contact between the sealing memberand the distal end of the balloon to enhance sealing the outlet. Forexample, the distal tip may be relatively thin compared to the distalend of the balloon such that, when the sealing member is directedproximally into the distal tip, the distal tip may expand and conform tothe shape of the sealing member. When the sealing member is directeddistally to open the outlet, the distal tip may resiliently return toits original size and/or shape.

In addition or alternatively, the elongate inner member may include a“J” or otherwise curved distal tip, e.g., extending distally from thesealing member or otherwise distally from the distal end of the innermember. The distal tip may be sufficiently flexible such that, when aguidewire or other instrument is advanced through the elongate memberinto the distal tip, the distal tip may be substantially straightened,which may facilitate advancing the apparatus over the guidewire. Whenthe guidewire is withdrawn from the distal tip, the distal tip mayresiliently return to its curved shape, which may facilitate locatingand/or advancing the apparatus into a branch from a main vessel or otherbody lumen.

Optionally, any of the apparatus herein may include a helical memberincluding a first end coupled to the tubular member distal end and asecond end coupled to the elongate member distal end, the helical memberextending helically around the elongate member within the ballooninterior. The elongate member may be movable to a third position inwhich the elongate member distal end is directed towards the tubularmember distal end to cause the helical member to compress axially andexpand radially outwardly, thereby expanding the balloon to an expandedhelical shape.

In accordance with still another embodiment, an apparatus is providedfor treating a body lumen that includes an outer member including aproximal end, a distal end sized for introduction into a body lumen, anda first lumen extending between the proximal and distal ends; and anexpandable balloon including a proximal end secured to the outer memberdistal end, and a distal end comprising an outlet, the balloon includingan interior communicating with the first lumen and the balloon outlet.An inner member is slidably disposed within the first lumen, the innermember including a proximal end adjacent the outer member proximal end,a distal end extending from the balloon outlet, and a sealing member onthe inner member distal end. The inner member may be movable between afirst position wherein the sealing member is spaced from the balloonoutlet such that fluid introduced through the first lumen passes throughthe balloon interior and out the balloon outlet, and biased to a secondposition wherein the sealing member substantially seals the balloonoutlet such that fluid introduced through the first lumen enters theballoon interior to expand the balloon. For example, a spring elementmay be provided between a spring stop in the balloon distal end and theinner member distal end for biasing the inner member towards the secondposition.

In accordance with yet another embodiment, an apparatus is provided fortreating a body lumen that includes an outer tubular member including aproximal end, a distal end, and a first lumen extending between theproximal and distal ends; an inner member slidably disposed within thefirst lumen; and an expandable balloon including a proximal end securedto the outer member distal end, an interior communicating with the firstlumen and a balloon outlet. The inner member includes a distal endextending from the balloon outlet, and carrying one or more sealingmembers. A helical member includes a first end coupled to the outermember distal end and a second end coupled to the inner member distalend, the helical member extending helically around the inner memberwithin the balloon interior.

The inner member may be movable relative to the outer member fordeploying the balloon in multiple modes. For example, the inner membermay be movable from a first position wherein the sealing member isspaced from the balloon outlet such that fluid introduced through thefirst lumen passes through the balloon interior and out the balloonoutlet, and a second position wherein the sealing member substantiallyseals the balloon outlet such that fluid introduced through the firstlumen enters the balloon interior to expand the balloon. In addition oralternatively, the inner member may be movable from the first or secondposition to a third position in which the inner member distal end isdirected proximally towards the outer member distal end to cause thehelical member to expand radially outwardly, thereby expanding theballoon to an expanded helical shape.

In accordance with still another embodiment, an apparatus is providedfor treating a body lumen that includes an outer tubular memberincluding a first lumen extending between proximal and distal endsthereof, an inner member slidably disposed within the first lumen, andan expandable balloon comprising a proximal end secured to the outermember distal end, and a distal end coupled to a distal end of the innermember. The balloon includes an interior communicating with the firstlumen such that inflation media may be delivered through the first lumeninto the balloon interior for expanding the balloon radially outwardlyfrom a contracted condition to an expanded condition, e.g., defining acylindrical or bulbous shape. The inner member may be movable axiallyrelative to the outer member for causing the balloon to compress axiallyand expand radially from the contracted condition to an expanded helicalshape.

For example, the apparatus may include a helical member extendinghelically around the inner member within the balloon interior, andincluding a first end coupled to the outer member distal end and asecond end coupled to the inner member. When the inner member is movedaxially, the helical member may be compressed axially and expandedradially outwardly, thereby directing the balloon to the expandedhelical shape.

Optionally, the inner member may include a second lumen extendingbetween the inner member proximal and distal ends, e.g., for receiving aguidewire or other rail. Thus, the apparatus may be advanced over aguidewire loaded through the second lumen. Once the balloon is disposedwithin a target body lumen, the inner member may be directed to one ormore of the first, second, and/or third positions, as desired, toperform various functions using the apparatus, e.g., without having toremove the apparatus and/or introduce another device into the bodylumen.

In accordance with yet another embodiment, an apparatus is provided fortreating a body lumen that includes an elongate outer member including aproximal end comprising a handle, a distal end sized for introductioninto a body lumen, and a first lumen extending between the proximal anddistal ends, and an expandable balloon including a proximal end securedto the outer member distal end, and a distal end comprising an outlet,the balloon including an interior communicating with the first lumen andthe balloon outlet. An inner member is slidably disposed within thefirst lumen, the inner member including a proximal end adjacent theouter member proximal end, a distal end extending from the balloonoutlet, and a sealing member on the inner member distal end. A firstactuator may be provided on the handle coupled to the inner member formoving the inner member between a first position wherein the sealingmember is spaced from the balloon outlet such that fluid introducedthrough the first lumen passes through the balloon interior and out theballoon outlet, and a second position wherein the sealing membersubstantially seals the balloon outlet such that fluid introducedthrough the first lumen enters the balloon interior to expand theballoon.

The apparatus may also include a helical member including a distal endcoupled to the inner member distal end and a proximal end disposedproximal to the distal end, the helical member extending helicallyaround the inner member within the balloon interior. A second actuatormay be provided on the handle coupled to the proximal end of the helicalmember for moving the helical member proximal end distally to cause thehelical member to compress axially and expand radially outwardly.

The helical member may be expanded and collapsed independent of movementof the inner member between the first and second positions. For example,a source of inflation media may be coupled to the apparatus forexpanding the balloon before activating the second actuator to expandthe helical member such that the helical member expands substantiallyunimpeded within the balloon interior. In addition or alternatively, asource of vacuum may communicate with the first lumen for collapsing theballoon after expanding the helical member such that the balloonconforms substantially to the shape of the helical member to adopt anexpanded helical shape. In an exemplary embodiment, both the source ofinflation media and the source of vacuum may be a single syringe fordelivering fluid into and removing fluid from the balloon interior toexpand and collapse the balloon.

In accordance with still another embodiment, an apparatus is providedfor treating a body lumen that includes an outer member including aproximal end, a distal end sized for introduction into a body lumen, anda first lumen extending between the proximal end and an outlet in thedistal end. An inner member may be slidably disposed within the firstlumen that includes a proximal end adjacent the outer member proximalend, and a distal end adjacent the outer member distal end. Theapparatus may also include an expandable balloon including proximal anddistal ends secured to the outer member distal end, and an interiorcommunicating with the first lumen via one or more openings in the outermember distal end.

A sealing member may be provided on the inner member distal end, and theinner member may be movable between a first position wherein the sealingmember is spaced from the outlet such that fluid introduced through thefirst lumen exits the outlet, and a second position wherein the sealingmember substantially seals the outlet such that fluid introduced throughthe first lumen enters the balloon interior to expand the balloon.Optionally, the inner member may be biased towards one of the first andsecond positions. For example, a spring element may be coupled between aspring stop in the balloon distal end and the inner member distal endfor enhancing a seal between the sealing member and the outlet and/orfor biasing the inner member towards the second position, e.g., toautomatically seal the outlet with the sealing member.

In accordance with yet another embodiment, an apparatus is provided fortreating a body lumen that includes an outer member including a proximalend, a distal end sized for introduction into a body lumen, and a firstlumen extending between the proximal and distal ends, and an expandableballoon including a proximal end secured to the outer member distal end,and a distal end including an outlet. The balloon may include aninterior communicating with the first lumen and the balloon outlet. Aninner member is slidably disposed within the first lumen, the innermember including a proximal end adjacent the outer member proximal end,a distal end extending from the balloon outlet, and a sealing member onthe inner member distal end. The inner member may be movable between afirst position wherein the sealing member is spaced from the balloonoutlet such that fluid introduced through the first lumen passes throughthe balloon interior and out the balloon outlet, and a second positionwherein the sealing member substantially seals the balloon outlet suchthat fluid introduced through the first lumen enters the ballooninterior to expand the balloon.

In addition, the balloon may include a distal tip extending distallyfrom the balloon distal end that is configured for facilitating openingand/or closing the outlet, e.g., for maximizing surface contact betweenthe sealing member and the distal tip when the inner member is in thesecond position for enhancing a seal of the outlet. For example, in oneembodiment, the sealing member may include a tapered proximal end, andthe balloon may include a distal tip extending distally from the balloondistal end, the distal tip biased to flare outwardly away from theballoon for receiving the tapered proximal end of the sealing membertherein.

In another embodiment, the sealing member may include a tapered proximalend, and the balloon may include a distal tip extending distally fromthe balloon distal end, the distal tip comprising flexible material suchthat the distal tip resiliently expands for receiving the taperedproximal end of the sealing member therein in the second position. Forexample, the distal tip may be configured to resiliently return towardsits original size when the inner member is directed from the secondposition to the first position to move the sealing member away from theballoon outlet.

Optionally, in any of these embodiments, a coating may be provided on aninner surface of at least a portion of the balloon distal end and/ordistal tip to reduce friction between the balloon distal end and/ordistal tip and the sealing member in the second position.

In another option, in any of these embodiments, the distal end of theballoon may be sized to provide a predetermined resistance to fluid flowtherethrough. For example, the spring stop or other feature within thedistal end may partially constrict the passage through the distal endleading to the outlet. Thus, if desired, with the outlet open, thedistal end may provide sufficient resistance to fluid flow therethroughthat fluid delivered into the balloon interior may at least partiallyexpand the balloon as well as deliver fluid through the outlet into abody lumen.

In accordance with still another embodiment, an apparatus is providedfor treating a body lumen that includes an outer member including aproximal end, a distal end sized for introduction into a body lumen, anda first lumen extending between the proximal end and an outlet in thedistal end; and an inner member slidably disposed within the firstlumen, the inner member comprising a proximal end adjacent the outermember proximal end, and a distal end extending distally beyond theouter member distal end. A sealing member is provided on the innermember distal end that includes one or more passages therethrough, andan expandable balloon is provided that includes a distal end secured tothe inner member distal end distally beyond the sealing member, and aproximal end secured to the sealing member such that an interior of theballoon communicates with the one or more passages. The inner member maybe movable between a first position wherein the sealing member is spacedfrom the outlet of the outer member such that fluid introduced throughthe first lumen passes through the outlet into a region around theapparatus, and a second position wherein the sealing membersubstantially seals the outlet such that fluid introduced through thefirst lumen passes through the one or more passages and enters theballoon interior to expand the balloon.

In accordance with another embodiment, a method is provided for treatinga body lumen of a patient using a balloon apparatus that includes anelongate shaft including a first lumen extending between proximal anddistal ends thereof, and a balloon carried on the distal end of theshaft that includes an outlet and an interior communicating with thefirst lumen and the outlet. The distal end of the shaft may beintroduced into a body lumen with the balloon in a contracted condition,and positioned relative to obstructive material within the body lumenthat is to be removed. Once positioned adjacent the obstructivematerial, the balloon may be expanded from the contracted condition toan expanded helical shape, and the distal end of the apparatus may bedirected along the body lumen with the balloon in the expanded helicalshape to remove the material from the body lumen. For example, thehelical shape of the balloon may enhance dislodging material adhered toa wall of the body lumen. Optionally, the balloon may include one ormore features, e.g., edges, grooves, and the like, to facilitateseparating adherent material from the wall of the body lumen. Ifdesired, the balloon may be returned to the contracted condition, movedto a new location within the body lumen, and again expanded to theexpanded helical shape to remove additional material within the bodylumen. Once sufficient material is removed, the balloon may be returnedto the contracted condition.

Before or after removing obstructive material from the body lumen,inflation media may be introduced through the first lumen into theballoon interior to expand the balloon from the contracted condition toan expanded condition, e.g., defining a substantially cylindrical shape.The balloon may be expanded to dilate an obstruction, lesion orotherwise treat a wall of the body lumen. After dilating the body lumen,the inflation media may be withdrawn from the balloon interior throughthe first lumen to collapse the balloon back towards the contractedcondition.

If the apparatus includes a valve adjacent the balloon for opening orclosing an outlet communicating with the first lumen and the ballooninterior, the valve may be closed before inflating the balloon.Optionally, at any time during the procedure, the valve may be opened,for example, to infuse fluid into the body lumen, e.g., for diagnosticand/or therapeutic purposes. During such infusion, the outlet of theballoon may provide substantially minimal resistance to fluid flow suchthat substantially all of the fluid delivered into the balloon exits theoutlet. Alternatively, the outlet may provide a predetermined resistanceto fluid flow therethrough such that some of the fluid delivered intothe balloon expands the balloon while the remaining fluid is deliveredthrough the outlet. After expanding the balloon one or more times, e.g.,to the cylindrical shape and/or helical shape, the distal end of theapparatus may be removed from the body lumen and/or entirely from thepatient's body with the balloon in the contracted condition.

In accordance with yet another embodiment, a method is provided fortreating a body lumen of a patient using a balloon apparatus includingan outer member including a first lumen extending between proximal anddistal ends thereof, an inner member slidable within the first lumen,and a balloon including a proximal end attached to the outer memberdistal end, a distal end including an outlet and an interiorcommunicating with the first lumen and the outlet. The distal end of theouter member may be introduced into a body lumen with the balloon in acontracted condition and the inner member in a proximal position suchthat the outlet is substantially sealed by a sealing member on the innermember distal end. An actuator on a proximal end of the apparatus may beactivated to move the inner member to a distal position consequentlydirecting the sealing member distally to open the outlet, and fluid maybe delivered through the first lumen such that the fluid passes throughthe balloon interior and exits the open outlet into the body lumen.

Thereafter, the inner member may be retracted proximally towards theproximal position to substantially seal the outlet with the sealingmember. Optionally, a spring element may be provided within the ballooninterior that provides sufficient bias to ensure that the sealing membersubstantially engages the balloon distal end to seal the outlet.Alternatively, the spring element may have sufficient bias such that,when the actuator is released such, the spring element automaticallyretracts the inner member towards the proximal position to substantiallyseal the outlet with the sealing member. Fluid may be delivered throughthe first lumen with the outlet substantially sealed, thereby expandingthe balloon from the contracted condition to an enlarged condition,e.g., for dilating a lesion or otherwise treating a body lumen.

Optionally, the balloon may be directed to an expanded helical shapewithin the body lumen, e.g., before or after expanding the balloon tothe enlarged condition, and the balloon may be directed along a wall ofthe body lumen in the expanded helical shape to remove material from thewall of the body lumen. In one embodiment, the balloon may be directedto the expanded helical shape by expanding the balloon at leastpartially towards the enlarged condition; expanding a helical memberwithin the balloon interior with the balloon at least partially expandedtowards the enlarged condition; and collapsing the balloon around theexpanded helical member such that the balloon conforms substantially tothe shape of the helical member. In another embodiment, the balloon maybe directed to the expanded helical shape by expanding a helical memberwithin the balloon interior with the balloon collapsed such that theballoon conforms substantially to the shape of the helical member. Inyet another embodiment, the balloon may be directed to the expandedhelical shape by directing the inner member proximally relative to theouter member, thereby compressing the balloon axially and expanding ahelical member within the balloon interior, the balloon conformingsubstantially to the shape of the helical member as the helical memberis expanded.

In accordance with still another embodiment, a method is provided fortreating a body lumen of a patient using a balloon apparatus includingan outer member including a first lumen extending between proximal anddistal ends thereof, an inner member slidable within the first lumen,and a balloon including a proximal end attached to the outer memberdistal end, a distal end including an outlet and an interiorcommunicating with the first lumen and the outlet. The distal end of theouter member may be introduced into a body lumen with the balloon in acontracted condition, and fluid may be delivered through the first lumenwith the outlet sealed, thereby expanding the balloon from thecontracted condition to an expanded condition. A helical member withinthe balloon interior may then be expanded with the balloon in theenlarged condition, and then the balloon may be collapsed around theexpanded helical member such that the balloon conforms substantially tothe shape of the helical member to define an expanded helical shape. Theballoon may then be directed along a wall of the body lumen in theexpanded helical shape to remove material from the wall of the bodylumen.

Optionally, in the expanded helical shape, the size of the helicalmember and balloon may be varied, as desired. For example, the helicalmember may be expanded to a size corresponding to the size of theparticular body lumen being treated, e.g., by sliding the inner memberto one of multiple positions that expands the helical member to thedesired size. Thus, the helical member and balloon may be able to treatdifferent size body lumens using a single apparatus.

In accordance with yet another embodiment, a method is provided fortreating a body lumen of a patient using an apparatus including an outertubular member including a first lumen extending between proximal anddistal ends thereof, and a balloon including a proximal end attached tothe outer member distal end, a distal end including an outlet and aninterior communicating with the first lumen and the outlet. Initially, adistal end of an elongate member may be introduced into a patient'sbody, e.g., via a percutaneous entry site, until the distal end isdisposed within a body lumen, the elongate member including a sealingmember on the distal end.

The distal end of the outer member may be advanced over the elongatemember with the balloon in a contracted condition, e.g., until theballoon outlet engages or is otherwise disposed adjacent the sealingmember. Optionally, an actuator on the outer member proximal end may becoupled to the inner member, and the actuator directed to a firstposition wherein the sealing member substantially seals the outlet.Fluid may then be delivered into the first lumen with the outletsubstantially sealed, thereby expanding the balloon to an enlargedcondition.

Either before or after expanding the balloon, the actuator may bedirected to a second position wherein the sealing member is spaced fromthe outlet, and fluid may be delivered into the first lumen, therebydelivering the fluid from the outlet into the body lumen. Optionally,once sufficient treatment has been completed, e.g., by expanding theballoon and/or by delivering fluid into the body lumen, the actuator maybe decoupled from the inner member, and the outer member removed fromaround the inner member, e.g., out of the patient's body. Alternatively,the outer and inner members may be removed substantially simultaneously.

In an alternative embodiment, the balloon may be expandable to anexpanded helical shape within the body lumen. If so, the balloon may bedirected along a wall of the body lumen in the expanded helical shape toremove material from the wall of the body lumen.

In accordance with still another embodiment, a method is provided fortreating a body lumen of a patient using an apparatus that includes anouter tubular member including a first lumen extending between proximaland distal ends thereof, a balloon including a proximal end attached tothe outer member distal end, a distal end including an outlet and aninterior communicating with the first lumen and the outlet, and ahelical member within the balloon interior. Initially, a distal end ofan elongate member may be introduced into a patient's body until thedistal end is disposed within a body lumen, the elongate memberincluding an enlarged member on the distal end.

The distal end of the outer member may be advanced over the elongatemember with the balloon in a contracted condition, e.g., until theballoon outlet engages or is otherwise disposed adjacent the sealingmember. At least one of the outer member and the inner member may bedirected axially relative to the other, e.g., to compress the balloonaxially and expand a helical member within the balloon interior. Theballoon may conform substantially to the shape of the helical member asthe helical member is expanded, e.g., to define an expanded helicalshape, and the balloon may be directed along a wall of the body lumen inthe expanded helical shape to remove material from the wall of the bodylumen.

In accordance with yet another embodiment, a method is provided fortreating a body lumen of a patient using a balloon apparatus includingan outer member that includes a first lumen extending between proximaland distal ends thereof, an inner member slidable within the firstlumen, and a balloon attached to a distal end of the inner member beyondthe outer member distal end. The distal end of the outer member may beintroduced into a body lumen with the balloon in a contracted condition.The inner member may be in a proximal position such that a sealingmember on the inner member substantially seals an outlet in the outermember distal end communicating with the first lumen, or the innermember may be in a distal position such that the sealing member isspaced apart from the outlet.

The inner member may be directed to a distal position, e.g., using anactuator on a proximal end of the outer member, consequently directingthe sealing member away from and opening the outlet. Fluid may bedelivered through the first lumen such that the fluid passes through theoutlet into the body lumen. Optionally, the inner member may be directedto an intermediate position wherein some of the fluid is delivered intothe body lumen and some of the fluid passes through one or more passagesin the sealing member into the balloon interior to at least partiallyexpand the balloon.

If desired, the inner member may be directed towards the proximalposition to substantially seal the outlet with the sealing member, andfluid may be delivered through the first lumen with the outletsubstantially sealed, thereby delivering the fluid through the one ormore passages in the sealing member to expand the balloon from thecontracted condition to an enlarged condition. The balloon may be usedto dilate or otherwise treat a body lumen. After sufficient treatment,the fluid may be aspirated from the interior of the balloon through theone or more passages and first lumen to return the balloon to thecontracted condition.

Other aspects and features of the present invention will become apparentfrom consideration of the following description taken in conjunctionwith the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

It will be appreciated that the exemplary apparatus shown in thedrawings are not necessarily drawn to scale, with emphasis instead beingplaced on illustrating the various aspects and features of theillustrated embodiments.

FIG. 1 is a side view of a first exemplary embodiment of an apparatusincluding a balloon for treating a body lumen, the apparatus operable ina first mode for minimizing a profile of the apparatus for introductioninto the body lumen, a second mode for infusing fluid into the bodylumen, and a third mode for removing material within the body lumen.

FIG. 2A is a side view of the apparatus of FIG. 1 in the first mode forminimizing a profile of the apparatus for introduction into a bodylumen.

FIG. 2B is a side view of the apparatus of FIG. 1 in the second mode forinfusing fluid into a body lumen.

FIG. 2C is a side view of the apparatus of FIG. 1 in the third mode inwhich the balloon is expanded for removing material within a body lumen.

FIG. 2D is a side view of the apparatus of FIGS. 1 and 2C in the thirdmode, showing a size of the balloon being increased to facilitateremoving material within a body lumen.

FIG. 3 is a side view of another embodiment of an apparatus including aballoon for treating a body lumen and a valve for selectively deliveringfluid from the apparatus.

FIGS. 4A and 4B are details of a distal end of the apparatus of FIG. 3showing the valve in closed and open positions, respectively.

FIGS. 5A-5C are cross-sectional views of a body lumen within a patient'sbody showing different methods for treating a body lumen using theapparatus of FIG. 3.

FIGS. 6A-6D are side view details of the apparatus of FIGS. 1 and 3,showing alternative configurations for the balloon.

FIG. 7 is a side view of yet another exemplary embodiment of anapparatus including a balloon for treating a body lumen, the apparatusoperable in a first mode for infusing fluid into the body lumen, asecond mode for dilating an obstruction within the body lumen, and athird mode for removing material within the body lumen.

FIGS. 7A-7H are cross-sections of the balloon of the apparatus of FIG.7, showing alternate constructions for integrally forming a helicalmember into the balloon.

FIG. 8 is a side view of still another exemplary embodiment of anapparatus including a balloon for treating a body lumen, the apparatusoperable in a first mode for dilating an obstruction within the bodylumen, and a second mode for removing material within the body lumen.

FIGS. 9A-9G are cross-sections of a body lumen showing exemplary methodsfor removing thrombus or other obstructive material from the body lumenand/or for dilating an obstruction within the body lumen using theapparatus of FIG. 7 or 8.

FIGS. 10A-10D are cross-sectional views of alternative embodiments ofballoon structures that may be provided on the apparatus of FIG. 8 toenhance removal of adherent material within a body lumen.

FIG. 11 is a side view of an alternative embodiment of the apparatus ofFIG. 7 or 8, including an obstruction removal balloon having differentsize coils in different regions of the balloon.

FIGS. 12 and 13 are cross-sectional views of a patient's body, showingmethods for treating an arterio-venous dialysis graft using theapparatus of FIG. 11.

FIG. 14 is a side view of another alternative embodiment of theapparatus of FIG. 11, including a dilation balloon adjacent theobstruction removal balloon.

FIG. 14A is a side view of another alternative embodiment of theapparatus of FIG. 11, including

FIGS. 15A and 15B are alternative embodiments of coil structures thatmay be provided within the balloon of any of the apparatus of FIGS.8-14.

FIG. 16 is a side view of yet another exemplary embodiment of anapparatus including a balloon for treating a body lumen, the apparatusoperable in a first mode for removing material within the body lumen,and in a second mode for dilating an obstruction within the body lumen.

FIGS. 17A-17D are side views of the apparatus of FIG. 10, showingoperation of the apparatus between an initial delivery configuration(FIG. 11A), the first mode for removing material within a body lumen(FIGS. 11B and 11C), and the second mode for dilating an obstructionwithin a body lumen (FIG. 11D).

FIGS. 18A-18C are cross-sectional views of a distal end of anotherembodiment of an apparatus including a balloon for treating a bodylumen, the apparatus operable in a first mode for dilating anobstruction within the body lumen, a second mode for infusing fluid intothe body lumen, and a third mode for removing material within the bodylumen.

FIGS. 19A-19C are side views of a proximal end of the apparatus of FIGS.18A-18C, showing an actuator on the proximal end directed between first,second, and third positions for operating the apparatus in the first,second, and third modes, respectively.

FIGS. 20A-20C are side views of an alternative embodiment of a proximalend that may be provided on the apparatus of FIGS. 18A-18C.

FIGS. 21A-21D are side views of the apparatus of FIGS. 18A-19C, showingthe apparatus being directed between different modes of operation.

FIGS. 22A-22D are side views of an alternative embodiment of theapparatus similar to the apparatus of FIGS. 18A-21D, but including aballoon and an expandable coil for treating a body lumen that isde-coupled from the balloon.

FIG. 23A is a perspective view of an apparatus, similar to that shown inFIG. 7, including a first exemplary embodiment of a handle for actuatingthe apparatus.

FIG. 23B is a cross-sectional detail of components of a rotary knobcontrol on the handle of FIG. 23A with a housing of the handle removedto show internal components.

FIG. 24A is a perspective view of another apparatus, similar to thatshown in FIG. 7, including a second exemplary embodiment of a handle foractuating the apparatus.

FIG. 24B is a cross-sectional detail of components of a slider controlon the handle of FIG. 24A with a housing of the handle removed to showinternal components.

FIG. 24C is a detail of an alternate slider control, similar to thatshown in FIGS. 24A and 24B, including visual indicators identifyingactuatable positions of the apparatus.

FIG. 25A is a perspective view of yet another apparatus, similar to thatshown in FIG. 7, including a third exemplary embodiment of a handle foractuating the apparatus.

FIG. 25B is a cross-sectional detail of components of a rotary wheelcontrol on the handle of FIG. 25A with a housing of the handle removedto show internal components.

FIG. 26A is a perspective view of still another apparatus, similar tothat shown in FIG. 7, including a fourth exemplary embodiment of ahandle for actuating the apparatus.

FIG. 26B is a cross-sectional detail of components of a squeeze controlon the handle of FIG. 26A with a housing of the handle removed to showinternal components.

FIG. 27A is a cross-sectional side view of a distal end of anotherembodiment of an apparatus including a balloon for treating a bodylumen.

FIG. 27B is a cross-sectional view of the apparatus of FIG. 27A takenalong line 27B-27B.

FIG. 28A is a perspective view of an exemplary embodiment of a handlethat may be provided on a balloon apparatus, such as the apparatus ofFIGS. 21A-22D.

FIG. 28B is a perspective view of components of the handle of FIG. 28Awith an outer housing of the handle removed.

FIG. 29 is a partially cross-sectional side view of still anotherexemplary embodiment of an apparatus for treating a body lumen.

FIGS. 30A and 30B are details of the distal end of the apparatus of FIG.29, showing a valve closed and open, respectively.

FIGS. 31A and 31B are details of an alternative embodiment of a distalend of the apparatus of FIG. 29, showing a valve closed and open,respectively.

FIG. 32 is a partially cross-sectional side view of yet anotherexemplary embodiment of an apparatus for treating a body lumen.

FIGS. 33A and 33B are partially cross-sectional side views of stillanother exemplary embodiment of an apparatus for treating a body lumen,including a guidewire inserted into and removed from the apparatus,respectively.

FIGS. 34A-34C are side views of alternative embodiments of handles thatmay be provided on an apparatus, such as the apparatus of FIGS. 29-33A.

FIG. 35 is a side view of a distal end of yet another exemplaryembodiment of an apparatus for treating a body lumen.

FIG. 36 is a perspective view of a distal end of still another exemplaryembodiment of an apparatus for treating a body lumen.

FIGS. 37A and 37B are details of the apparatus of FIG. 36 showing thevalve in open and closed positions, respectively.

FIG. 37C is a cross-sectional view of the apparatus of FIGS. 36-37Btaken along line 37C-37C of FIG. 37B.

FIG. 38 is a cross-sectional view of an alternative embodiment of theapparatus of FIGS. 36-37C.

FIG. 39 is a perspective view of a distal end of yet another exemplaryembodiment of an apparatus for treating a body lumen.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

Turning to the drawings, FIGS. 1-2D show a first exemplary embodiment ofan apparatus 10 for treating a body lumen, e.g., for infusing fluid intoa body lumen and/or for removing thrombus, objects, and/or obstructivematerial from within a body lumen, such as a blood vessel, aorto-venousfistula, tubular graft, and the like (not shown). Generally, theapparatus 10 includes a catheter, sheath, or other tubular outer member20, a core wire, shaft, or other elongate inner member 30, and anexpandable balloon 50 carried by the inner and/or outer members 20, 30.The apparatus 10 may be operable in multiple modes, for example, toperform various treatments or other functions within a body lumen, e.g.,to reduce or eliminate the need to exchange multiple devices during aprocedure within a body lumen. For example, the apparatus 10 may beoperable in a first mode for minimizing a profile of the apparatus 10,e.g., to facilitate introduction into a patient's body (FIG. 2A), asecond mode for infusing fluid into a body lumen (FIG. 2B), and a thirdmode for removing material within a body lumen (FIGS. 2C and 2D), asdescribed further below.

As best seen in FIG. 1, the outer member 20 includes a proximal end 22,a distal end 24 sized for introduction into a body lumen, and a firstlumen 26 extending therebetween. The outer member 20 may have asubstantially uniform construction along its length, or alternatively,the construction may be varied. For example, a proximal portion of theouter member 20 may be substantially rigid or semi-rigid to facilitateadvancement of the apparatus 10 from the proximal end 22 and/or a distalportion of the outer member 20 may be flexible, e.g., to facilitatebending and/or advancement through tortuous anatomy without substantialrisk of kinking or buckling. In exemplary embodiments, the outer member20 may be formed from materials such as metal, plastic, e.g., PEEK,Grilamed L25, and the like, or composite materials. The outer member 20may have a length between about thirty and one hundred thirtycentimeters (30-130 cm) and an outer diameter between about 1.2 and 2.0millimeters, and the first lumen 26 may have a diameter between about1.0 and 1.8 millimeters.

The inner member 30 also includes a proximal end 32, a distal end 34,and, optionally, may include a second lumen 36 extending between theproximal and distal ends 32, 34, which may be sized to slidably receivea guide wire, or other rail (not shown) therethrough, e.g., having adiameter between about 0.3 and 1.0 millimeter. The inner member 30 issized to be slidably received within the first lumen 26 of the outermember 20, e.g., such that an annular space is defined between the outerand inner members 20, 30 for passing one or more fluids therethrough, asdescribed further below. The inner member 30 may have a length relativeto the outer member 20 such that the inner member proximal end 32 isreceived within or extends proximally beyond the outer member proximalend 22 and the inner member distal end 34 extends distally beyond theouter member distal end 24, e.g., through the balloon 50, as describedfurther below.

The balloon 50 includes a proximal end 52 coupled to the outer memberdistal end 24, a distal end 54 defining an outlet 58, and an interior 56communicating with the first lumen 26 and the outlet 58. The proximalend 52 of the balloon 50 may be attached or otherwise secured to thedistal end 24 of the outer member 20 to provide a fluid-tightconnection, e.g., by one or more of bonding with adhesive, interferencefit, sonic welding, fusing, engagement with a surrounding sleeve orother connector (not shown), and the like.

The distal end 34 of the inner member 30 may extend through the distalend 54 of the balloon 50, e.g., such that the outlet 58 defines anannular passage between the distal end 54 of the balloon 50 and thedistal end 34 of the inner member 30. The size of the outlet 58 may besubstantially the same as the size of the first lumen 26, oralternatively, the outlet 58 may be larger or smaller than the firstlumen 26, as desired, depending on the desired degree of friction orresistance to fluid flow through the outlet 58. For example, with theoutlet 58 open to allow fluid flow, the resistance to fluid flowingthrough the outlet 58 may be substantially less than the resistance ofthe balloon 50 to expansion, such that the fluid preferentially flowsthrough the outlet 58, rather than expanding the balloon 50, asdescribed further below.

Alternatively, as shown in FIGS. 27A and 27B, an apparatus 10′ may beprovided that includes an outer member 20′ and/or an inner member 30′that include multiple lumens. For example, as best seen in FIG. 27B, theouter member 20′ may include a first lumen 26 a′ for slidably receivingthe inner member 30′ and a separate inflation lumen 26 b′ for deliveringfluid into the interior 56′ of the balloon 50.′ This alternative mayallow a profile of the outer member 20′ to be reduced since lessclearance may be needed around the inner member 30′ in the first lumen26 a.′ In addition or alternatively, the inner member 30′ may include afirst instrument lumen 36 a′ for receiving a guidewire 99′ or otherinstrument, and a second fluid lumen 36 b′ for delivering and/oraspirating fluid beyond the distal end 34′ of the inner member 30.′

Returning to FIG. 1, the distal end 54 of the balloon 50 may beintegrally formed with the main wall of the balloon 50 (defining theinterior 56), and, optionally the proximal end 52 of the balloon 50. Forexample, the balloon 50 and its proximal and distal ends 52, 54 may bemolded, blown, or otherwise formed from a single tubular section ofmaterial. Optionally, the main wall of the balloon 50 may be relativelythin compared to the distal end 54, e.g., such that the distal end 54 ofthe balloon 50 maintains its original size and/or shape as the balloon50 is expanded.

For example, the distal end 54 of the balloon 50 may be sufficientlythick and/or rigid to provide a sealing ring on the distal end 54.Optionally, the distal end 54 of the balloon 50 may include one or moreadditional features, e.g., surrounding or otherwise defining the outlet58 and/or reinforcing the distal end 54. For example, the distal end 54may include a collar or sleeve (not shown, see, e.g., sleeve 155 shownin FIG. 7), within or around the distal end 54, e.g., attached orotherwise secured to the distal end 54, e.g., by bonding with adhesive,interference fit, sonic welding, fusing, and the like.

The balloon 50 may be formed from elastic material, e.g., to provide acompliant or semi-compliant balloon that may be expanded to a variety ofsizes and/or shapes, e.g., based on the amount of fluid and/or pressurewithin the interior 54 of the balloon 50 and/or the relative position ofthe inner member 30, as described further below. Alternatively, theballoon 50 may be formed from substantially inelastic material, e.g., toprovide a non-compliant balloon that expands to a predetermined sizewhen inflated independent of pressure (once a minimum volume and/orpressure is introduced to achieve the predetermined size). Such anon-compliant balloon 50 may expand to the predetermined size even ifinflated to relatively high pressures, e.g., until the balloon 50 burstsor otherwise ruptures, e.g., at pressures of at least ten atmospheres,twenty atmospheres, thirty atmospheres, and the like.

One or more sealing members 38 may be carried on the inner member distalend 34, e.g., such that the sealing member(s) 38 are movable relative tothe balloon 50 as the inner member 30 is moved, e.g., for selectivelyopening and closing the outlet 58 of the balloon 50 to provide a valve,as described further below. The sealing member(s) 38 may be formed fromflexible materials, e.g., which may enhance engagement with the balloondistal end 54, such as elastomeric materials, e.g., silicone, or otherplastics, e.g., PEBAX.

As best seen in FIG. 1, a first sealing member 38 a may be provided onthe inner member 30 proximal to or otherwise adjacent a second sealingmember 38 b. The sealing member(s) 38 may be disposed adjacent a distaltip 35 of the inner member 30 or may extend beyond the distal tip 35.The distal tip 35 (or the sealing member extending beyond the distal tip35) may be substantially atraumatic, e.g., rounded, softened, providedwith a “J” tip, and the like (not shown), to facilitate advancement ofthe apparatus 10 within a patient's body without substantial risk of thedistal tip 35 puncturing or otherwise damaging walls of body lumensthrough which the distal tip 35 passes.

The sealing member(s) 38 may have a size, e.g., outer diameter, that islarger than the distal end 54 of the balloon 50, e.g., larger than theinner diameter of the outlet 58. As shown in FIG. 1, the sealing members38 are spaced apart sufficiently from one another such that the distalend 54 of the balloon 50 is free floating between the sealing members38. When the inner member 30 is directed axially, one of the sealingmembers 38 may engage or otherwise contact the distal end 54 of theballoon 50. The sealing member(s) 38 may have tapered shapes tofacilitate seating or other engagement by the sealing member(s) 38 withthe distal end 54.

For example, with additional reference to FIG. 2A, the inner member 30may be directed distally to a first or distal position wherein the firstsealing member 38 a pushes or otherwise contacts the distal end 54, andthe second sealing member 38 b is spaced from the balloon outlet 58. Asshown, the inner member 30 may be advanced distally to cause the firstsealing member 38 a to push the distal end 54. Because the outerdiameter of the first sealing member 38 a is larger than inner diameterof the distal end 54, the first sealing member 38 a pushes the distalend 54 of the balloon 50 away from the proximal end 52tie, therebystretching the balloon 50. This configuration may minimize or otherwisereduce the profile of the balloon 50, e.g., to facilitate introductioninto a patient's body. In this first position, the first sealing member38 a may substantially seal the outlet 58, although alternatively, thefirst sealing member 38 a may include one or more axial grooves or otherfeatures that allow at least some fluid to pass through the outlet 58even when the first sealing member 38 a is seated or pushing against thedistal end 54.

Turning to FIG. 2B, the inner member 30 may be directed axially to asecond position, e.g., proximal to the first position, such that thedistal end 54 of the balloon 50 is disposed between the sealing members38 a, 38 b and the outlet 58 is substantially open. Thus, fluidintroduced through the first lumen 26 of the outer member 20 may passthrough the balloon interior 56 and exit through the outlet 58, e.g.,between the balloon distal end 54 and inner member distal end 24 intothe body lumen beyond the distal tip 35.

As shown in FIG. 2C, the inner member 30 may also be directed proximallyto a third position, e.g., proximal to the second position, in which thesecond sealing member 38 b engages the distal end 54 of the balloon 50,thereby substantially sealing the outlet 58 from fluid flowtherethrough. Thus, any fluid introduced through the first lumen 26enters the balloon interior 56 and expands the balloon 50. Optionally,as shown in FIG. 2D, once the balloon 50 is expanded, the inner member30 may be directed further proximally, e.g., to an indefinite number ofpositions wherein the second sealing member 38 b continues to seal theoutlet 58, and the size and/or shape of the expanded balloon 50 may bechanged. For example, as shown in FIG. 2C, with the inner member 30 inthe third position, the balloon 50 may be inflated to an elliptical orgenerally spherical shape, e.g., by delivering a predetermined volume offluid into the interior 56 of the balloon 50. If the balloon 50 iscompliant, one of a range of desired volumes may be delivered into theinterior 56 to expand the balloon 50 to a desired diameter.

With further reference to FIG. 2D, thereafter, as the inner member 30 isdirected proximally further, the distal end 54 of the balloon 50(captured between the sealing members 38) is also directed proximally,i.e., towards the proximal end 52 of the balloon 50, thereby compressingthe balloon 50 axially and expanding the balloon 50 further.

As shown in FIG. 6A, the balloon 50 wall may have a substantiallyuniform wall thickness between the proximal and distal ends 52, 54.Thus, when the balloon is compressed, as shown in FIG. 2D, the proximaland/or distal ends 52, 54 of the balloon 50 may at least partially evertinto the interior 56 of the balloon 50. Thus, the wall of the balloon 50may fold over onto the outside of the proximal and/or distal ends 52, 54as the inner member 30 is directed proximally from the third position.

Alternatively, as shown in FIG. 6B, the thickness of the balloon 50 amay be reduced along its length, e.g., thinning from the proximal anddistal ends 52 a, 54 a towards a central region 55 a of the balloon 50a. Thus, the regions of the balloon 50 a immediately adjacent theproximal and distal ends 52 a, 54 a may be relatively rigid compared tothe central region 55 a. When the balloon 50 a is compressed afterexpansion, the regions immediately adjacent the proximal and distal ends52 a, 54 a may resist the balloon 50 a everting and the thinner centralregion 55 a may expand to a greater diameter compared to the balloon 50of FIG. 6A.

In further alternatives, shown in FIGS. 6C and 6D, the regions of theballoon 50 b, 50 c immediately adjacent the proximal and/or distal ends52,b 54 b or 52 c, 54 c may be reinforced further, e.g., includingadditional materials, to reinforce the base of the balloon 50 b, 50 c toreduce everting and/or otherwise preferentially control expansion of theballoon 50 b, 50 c. For example, in FIG. 6C, composite materials 53 bhave been embedded or otherwise provided in the balloon materialadjacent the proximal and distal ends 52 b, 54 b, while in FIG. 6D, anadditional layer of material 53 c has been added, which may be the samematerial or different material than the rest of the balloon 50 c. Thelayer may be attached to the balloon 50 c, e.g., similar to thematerials and methods described elsewhere herein for attaching theballoon 50 c to the outer member 20.

Returning to FIG. 1, a handle or hub 60 may be coupled to or otherwiseprovided on the proximal end 22 of the outer member 20, e.g., formanipulating the outer member 20 and/or the entire apparatus 10. Thehandle 60 may have an ergonomic shape, e.g., to facilitate holdingand/or manipulating the handle 60, and including one or more controls oractuators for actuating the components of the apparatus 10. For example,as shown, a pull handle 62 may be provided adjacent the main handle 60that is coupled to the inner member 30. Thus, to move the inner member30 to the various positions described above, the pull handle 62 may bepushed or pulled, e.g., pushed distally to direct the inner member 30 tothe first position shown in FIG. 2A, and pulled proximally to direct theinner member 30 to the second and third (or further proximal) positions,shown in FIGS. 2B-2D. Alternatively, similar to the embodiments shown inFIGS. 11 and 14, a slider actuator (not shown) may be provided on thehandle 60 that is coupled to the inner member 30 for directing the innermember 30 axially relative to the handle 60 and outer member 20. In afurther alternative, a wheel or other actuator may be provided fordirecting the inner member 30 axially relative to the outer member 20.

The pull handle 62 and/or inner member 30 may be biased to one of thepositions shown in FIGS. 2A-2D, e.g., by one or more springs or otherbiasing mechanisms (not shown) within the handle 60. For example, theinner member 30 may be biased to the second (infusion) position, but maybe directed to the other positions by overcoming the bias.Alternatively, the handle 60 may include one or more features, e.g.,pockets, notches, and the like (not shown), providing tactile feedbackand/or for releasably securing the inner member 30 in one of thepositions. In addition or alternatively, the handle 60 may include oneor more visual markers (not shown), e.g., to inform the user when thevarious positions are achieved. In a further alternative, the firstsealing member 38 a may be eliminated and the first position eliminated,e.g., if there is less concern with profile of the apparatus 10 duringintroduction and/or to simplify operation of the apparatus 10.

With continued reference to FIG. 1, the handle 60 may also include oneor more ports for coupling one or more fluid sources to the apparatus10, such as a source of inflation media, a source of vacuum, and/or asource of diagnostic and/or therapeutic agents (not shown). For example,as shown, a side port 64 may communicate with the first lumen 26. Theside port 64 may include one or more connectors (not shown) tofacilitate coupling one or more sources of fluid to the side port 64,e.g., a Luer lock connector, and/or one or more seals, e.g., ahemostatic seal, to prevent fluid from leaking from the side port 64.

A syringe or other source of fluid (not shown) may be coupled to theside port 64 to allow delivery of the fluid through the first lumen 26into the interior 56 of the balloon 50 and/or through the outlet 58,depending upon the position of the inner member. For example, if theinner member 30 is in the second (infusion) position, contrast material,e.g., radiopaque, echogenic, or other fluid that facilitates observationusing fluoroscopy, ultrasound, or other external imaging, may bedelivered through the first lumen 26 and outlet 58 into a body lumen.Such material may facilitate monitoring the apparatus 10 duringadvancement through a patient's body into a target body lumen and/or toidentify the status of treatment of a body lumen, as described furtherbelow. With the inner member 30 in the third position, the same fluidmay be delivered through the first lumen 26 to expand the balloon 50, orthe source of contrast material may be replaced with a source of adifferent fluid, e.g., a syringe of saline, to facilitate expansionand/or collapse of the balloon 50.

Alternatively, multiple ports may be provided that communicate with thefirst lumen 26, e.g., such that various fluids may be deliveredselectively through the first lumen 26 depending upon the desiredfunction. For example, a source of contrast and a source of saline couldbe coupled to different ports such that each fluid may be deliveredindependently depending upon the position of the inner member 30 withouthaving to change out the sources. Alternatively, a source of one or moretherapeutic agents may be coupled to the side port 64 (or to a separateport), e.g., when desired, to deliver the agent(s) into the target bodylumen.

Optionally, the handle 60 may include one or more seals, bushings, andthe like to facilitate relative motion of the outer and inner members20, 30 and/or to seal the first lumen 26. For example, as shown in FIG.1, an o-ring 66 may be provided between the outer and inner members 20,30, which may guide the inner member 30 as it moves axially relative tothe outer member 30 and handle 60. The o-ring 66 may also be locatedproximal to the side port 64, thereby providing a substantiallyfluid-tight seal between the outer and inner members 20, 30 to preventleakage of fluid introduced into the side port 64 from the handle 60.

As shown, the pull handle 62 includes a port 63 for receiving aguidewire or other rail (not shown) therethrough. For example, aguidewire may be introduced into the second lumen 36 of the inner member30, e.g., from the port 63 or by backloading into the inner memberdistal end 34. The port 63 may include one or more seals, e.g., ahemostatic seal (not shown), to accommodate passage of a guidewiretherethrough without risk of substantial risk of leakage of blood orother body fluids from the second lumen 36.

Optionally, the outer member 20 may include one or more additionallumens (not shown) extending between the proximal and distal ends 22,24, e.g., a guidewire lumen for receiving a guidewire or other rail (notshown), e.g., if the inner member 30 does not include the second lumen36, an inflation lumen for delivering inflation media to another balloon(not shown) on the distal end 24, and the like.

In addition or alternatively, if desired, the apparatus 10 may includeone or more markers to facilitate positioning and/or advancement of theapparatus 10 during use. For example, one or more radiopaque markers maybe provided on the outer member distal end 24, on the inner member 30within or adjacent the balloon 50 or distal tip 35, on the balloon 50,e.g., on the proximal and/or distal ends 52, 54, and/or on the sealingmember(s) 38. Alternatively, one or more components of the apparatus 10may be formed from radiopaque or other materials that may facilitateimaging the apparatus 10 during use. For example, radiopaque markersand/or materials may facilitate positioning or otherwise imaging theapparatus 10 using fluoroscopy or other x-ray imaging, e.g., whenpositioning the balloon 50 (either before or after expansion) and/orwhen infusing fluid via the outlet 48. Alternatively, echogenic markersand/or materials may be provided to facilitate imaging using ultrasoundor similar imaging techniques.

With continued reference to FIGS. 2A-2D, an exemplary method will now bedescribed for treating a body lumen (not shown), e.g., using anapparatus 10, which may be any of the embodiments described herein, andnot necessarily limited to the embodiment shown and described below withreference to FIG. 1. The target body lumen may be a blood vessel, e.g.,a vein or artery, a graft, e.g., an aorto-venous fistula, tubularxenograft, or synthetic tubular graft, and the like. For example, thebody lumen may be a passage communicating between an adjacent artery andvein (not shown), e.g., in an arm or other region of a dialysis patient.Alternatively, the body lumen may be a blood vessel within a patient'svasculature, e.g., a peripheral vessel in a patient's leg, a cerebralvessel, and the like. In a further alternative, the material may be astone within a patient's urinary tract or other foreign object to beremoved from the patient's body.

Optionally, the body lumen may be accessed using one or more additionalinstruments (not shown), which may be part of a system or kit includingthe apparatus 10. For example, an introducer sheath, guide catheter, orother tubular member (not shown) may be introduced adjacent the targetsite where the material is to be removed, or may be introduced elsewherein the patient's body to provide access to the patient's vasculature orother passages communicating with the body lumen. If the body lumen islocated in a peripheral vessel of the patient, a percutaneous punctureor cut-down may be created using a needle or other instrument (notshown) at a peripheral location, such as a femoral artery, carotidartery, or other entry site (also not shown), and an introducer sheathmay be placed through the puncture at the peripheral location to provideaccess. The apparatus 10 may be advanced through the patient'svasculature from the entry site, e.g., alone or with the aid of a guidecatheter, guidewire, and the like (not shown).

For example, to facilitate directing the apparatus 10 from an entry siteto the target body lumen, a guide catheter, micro-catheter, or othertubular body may be placed from the entry site to the body lumen usingconventional methods. In addition or alternatively, a guidewire (notshown) may be placed from the entry site to the body lumen if desired,e.g., if the inner member 30 includes the second lumen 36. The tubularbody may also be used for aspiration, e.g., coupled to a source ofvacuum for capturing material removed by the apparatus 10.

Initially, with reference to FIG. 2A, the apparatus 10 may be advancedinto the body lumen with the inner member 30 in the second or distalposition, e.g., such that the balloon 50 is stretched to reduce itsprofile. Optionally, if the first sealing member 38 a does not seal theoutlet 58, one or more fluids may be delivered into the body lumen,e.g., to facilitate imaging and/or positioning the apparatus 10.Alternatively, the inner member 30 may be directed to the firstposition, shown in FIG. 2B, and fluid delivered to facilitate imaging.

For example, radiopaque contrast or other fluid may be delivered intothe body lumen via the annular passage defined by the first lumen 26between the outer and inner members 20, 30 to facilitate locating and/ormeasuring the size of the material 92 using fluoroscopy. Markers (notshown) on the apparatus 10 may facilitate positioning the balloon 50relative to material intended to be removed before the balloon 50 isexpanded, e.g., to facilitate verifying that the balloon 50 ispositioned distal to or otherwise beyond the material. If desired, theinner member 30 may be directed back and forth between the first andsecond positions, e.g., to allow infusion of contrast and to reduce theprofile of the apparatus 10 to facilitate further advancement, e.g.,until the balloon 50 is located beyond obstructive material targeted forremoval.

Optionally, the apparatus 10 may be introduced through a guide catheteror other tubular member (not shown), that includes a lumen communicatingwith a source of vacuum. With the balloon 50 disposed beyond the guidecatheter but not yet expanded, the source of vacuum may be activated toaspirate material within the body lumen during the subsequent treatment.

Turning to FIG. 2C, the inner member 30 may be directed to the thirdposition, thereby sealing the outlet 58, and the balloon 50 may beinflated within the body lumen, e.g., such that the balloon 50 extendssubstantially entirely across the body lumen. The entire apparatus 10may then be retracted to pull the occlusive material from the bodylumen, e.g., to be aspirated into guide catheter, or otherwise removedfrom the body lumen. As shown in FIG. 2D, if desired, the inner member30 may be pulled to further expand the balloon 50, e.g., tosubstantially engage the wall of the body lumen. The additional pressurefrom the balloon 50 may facilitate separating adherent material from thewall of the body lumen and allow its removal.

Once material is removed, the inner member 30 may be directed backtowards the second position, and fluid introduced to observe the amountof material removed and/or remaining within the body lumen. Ifadditional material is to be removed, the inner member back be directedto the first position, e.g., if desired to advance the apparatus 10through additional material to be removed. Once the balloon 50 islocated beyond the material, the process may be repeated as often asdesired.

If desired, the obstructive material may be treated, e.g., at leastpartially dissolved, macerated, and the like before, during, or afterwithdrawal. For example, a therapeutic agent may be delivered into thebody lumen via the first lumen 26 of the outer member 20, e.g., to atleast partially dissolve or separate thrombus or other relatively softmaterial before being removed by the balloon 50 and/or otherwise totreat the wall of the body lumen.

Because a single lumen, i.e., the first lumen 26, is used for bothinflation of the balloon 50 and delivering fluid into the body lumen,the profile of the outer member 20 and therefore of the overallapparatus 10 may be smaller than devices that include separate inflationand infusion lumens. Further, although the second lumen 36 of the innermember 30 could be used for infusion of fluids, this would generallyrequire removing the guidewire over which the apparatus 10 is introducedsince the guidewire may substantially fill the second lumen 36. Becausethe first lumen 26 may be used for infusion, the guidewire may remainwithin the second lumen 36 throughout the procedure, thereby potentiallyreducing the number of guidewire or other device exchanges. Further, theapparatus 10 may remain over the guidewire, which may facilitateadvancing the apparatus 10 to other target body lumens intended fortreatment.

In various alternatives, the valve created by the sealing member(s) 38and the outlet 58 of the balloon 50 may be provided at other locationson the apparatus 10, if desired. For example, the configuration may bereversed such that the outlet 58 and sealing members 38 may be locatedproximal to the balloon 50. For example, a sealing member (not shown)may be provided on the distal end 24 of the outer member 20, and theproximal end 52 of the balloon 50 may float adjacent the sealingmember(s), with the distal end 54 of the balloon 50 is secured to thedistal end 34 of the inner member 30 (also not shown). Thus, movement ofthe inner member 30 relative to the outer member 20 may cause theballoon proximal end to selectively engage or disengage the sealingmember(s), allowing infusion from the first lumen 24 when the balloonproximal end is not engaged with the sealing member(s) and allowingballoon inflation when the balloon proximal end engages the sealingmember(s). Alternatively, as shown in FIGS. 36-37C, an outlet 1027 maybe provided on the distal end 1024 of the outer member 1020 that may beselectively engaged with a sealing member 1038 on the inner member 1030proximal to the balloon 1050, as described further below.

In another alternative, a balloon (not shown) may be provided on thedistal end 24 of the outer member 20 proximal to the balloon 50 and/oron the distal end 34 of the inner member 30 distal to the balloon 50, ifdesired, similar to other embodiments described herein. Such a balloonmay be a non-compliant, high pressure balloon, e.g., for dilating thebody lumen, or an elastic, compliant balloon for substantially sealingthe body lumen to isolate one or more regions of the body lumen beforeinfusion of fluid therein.

Turning to FIGS. 3-4B, another embodiment of an apparatus 10″ is shownfor treating a body lumen that includes an outer tubular member 20,″ aninner member 30,″ and an expandable balloon 50″ carried by the innerand/or outer members 20,″ 30,″ which may be constructed similar to theapparatus 10 of FIG. 1. Also similar to the previous embodiments, theapparatus 10″ may be operable in multiple modes, for example, a firstmode for expanding the balloon 50″ (FIG. 4A), e.g., to remove material,dilate, or otherwise treat a body lumen, and a second mode fordelivering fluid into a body lumen (FIG. 4B), as described furtherbelow.

As best seen in FIG. 3, the outer member 20″ includes a proximal end22,″ a distal end 24″ sized for introduction into a body lumen, and afirst lumen 26″ extending therebetween. The inner member 30″ alsoincludes a proximal end 32,″ a distal end 34,″ and, optionally, mayinclude a second lumen 36″ extending between the proximal and distalends 32,″ 34,″ which may be sized to slidably receive a guide wire orother instrument (not shown) therethrough. The balloon 50″ includes aproximal end 52″ coupled to the outer member distal end 24,″ a distalend 54″ including an outlet 58,″ and an interior 56″ communicating withthe first lumen 26″ and the outlet 58.″ The distal end 54″ of theballoon 50″ may be integrally formed with the main wall of the balloon50″ (defining the interior 56″), and, optionally the proximal end 52″ ofthe balloon 50.″ The balloon 50″ may be formed from elastic material,e.g., to provide a compliant or semi-compliant balloon, or fromsubstantially inelastic material, e.g., to provide a non-compliantballoon, similar to other embodiments herein.

As best seen in FIGS. 4A and 4B, a sleeve 70″ may be attached to orotherwise provided on the distal end 54″ of the balloon 50,″ e.g., forsurrounding or otherwise defining the outlet 58″ and/or reinforcing thedistal end 54.″ For example, the sleeve 70″ may be a length ofsubstantially rigid tubing or other tubular body attached to the innersurface of the distal end 54″. The distal end 34″ of the inner member30″ may extend through the sleeve 70,″ e.g., such that the outlet 58″defines an annular passage between the sleeve 70″ and the distal end 34″of the inner member 30.″

As shown, the sleeve 70″ is longer than the distal end 54″ such that afirst end 72″ of the sleeve 70″ extends proximally from the distal end54″ into the interior 56″ of the balloon 50″ and a second end 74″ of thesleeve 70″ extends distally from the distal end 54″ to define the outlet58.″ The first end 72″ of the sleeve 70″ includes one or more holes orother apertures 73″ (two shown) in a side wall thereof, e.g., to providea fluid passage into the sleeve 70″ as described further below.

A sealing member 38″ may be carried on the inner member distal end 34,″e.g., such that the sealing member 38″ is movable relative to theballoon 50″ as the inner member 30″ is moved, e.g., for selectivelyopening and closing the outlet 58″ to provide a valve, as describedfurther below. For example, the sealing member 38″ may have a size,e.g., outer diameter, that is larger than the inner diameter of thesleeve 70″ and/or the outlet 58.″ Optionally, the sealing member 38″ mayhave a tapered shape, e.g., to facilitate seating or other engagement bythe sealing member 38″ with the outlet 58.″ In addition oralternatively, the second end 74″ of the sleeve 70″ may have a taperedshape, e.g., to facilitate and/or enhance seating and/or sealing theoutlet 58″ with the sealing member 38.″

The sealing member 38″ may be formed from flexible material, e.g., whichmay enhance engagement with the second end 74″ of the sleeve 70,″similar to other embodiments herein. Optionally, the sealing member 38″(or the inner member 30″) may include a substantially atraumatic distaltip 35,″ e.g., a rounded, softened, beveled, or “J” or other curved tip,(not shown), similar to other embodiments herein.

In addition, a stop 78″ may be provided on the inner member distal end34″ for limiting distal movement of the inner member 30″ relative to thedistal end 54″ of the balloon 50″ As best seen in FIGS. 4A and 4B, thestop 78″ may be attached to the inner member distal end 34″ at alocation spaced apart from the sealing member 38″ such that a distancebetween the stop 78″ and the sealing member 38″ is longer than thelength of the sleeve 70.″ Thus, the distal end 54″ of the balloon 50″may be free floating between the sealing member 38″ and the stop 78″ toprovide a valve for selectively opening and closing the outlet 58,″similar to other embodiments herein.

For example, as shown in FIG. 4A, the inner member 30″ may be directedproximally to direct the sealing member 38″ into engagement with thesecond end 74″ of the sleeve 70″ to substantially seal the outlet 58.″The sealing member 38″ and/or sleeve 74″ may be sufficiently flexible tocontact one another with a relatively high contact pressure, e.g., bydeformation of one or both of the sealing member 38″ and/or sleeve 74,″to provide a substantially fluid-tight seal. Thus, in this position,fluid delivered into the first lumen 26″ of the outer member 20″ mayremain within the balloon interior 56″ to expand the balloon 40.″

Turning to FIG. 4B, the inner member 30″ may be directed distally, e.g.,until the stop 78″ contacts the sleeve 70,″ thereby opening the outlet58.″ Thus, fluid delivered into the first lumen 26″ passes through theballoon interior 56″ and through the sleeve 70″ and outlet 58″ into thebody lumen beyond the apparatus 10.″ As shown, the stop 78″ and sleeve70″ may have substantially flat and/or blunt end surfaces that contactone another, e.g., to provide a relatively low contact pressure betweenthe stop 78″ and sleeve 70.″ The hole(s) 73″ ensure that fluid deliveredthrough the balloon interior 56″ enters the sleeve 70″ and exits theoutlet 58,″ e.g., if a restriction or seal results between thecontacting end surfaces of the stop 78″ and sleeve 70.″

In one embodiment, fluid may be delivered from the outlet 58″ withminimal or no expansion of the balloon 50.″ Alternatively, the size ofthe holes 73″ may be selected such that some friction results when fluidis delivered therethrough such that the balloon 50″ expands at leastpartially while still delivering fluid through the outlet 58″ into thebody lumen.

Optionally, the inner member 30″ may be advanced to press the stop 78″against the sleeve 70″ and push the distal end 54″ of the balloon 50″away from the proximal end (not shown), thereby stretching the balloon50.″ This configuration may minimize or otherwise reduce the profile ofthe balloon 50,″ e.g., to facilitate introduction into a patient's body.Alternatively, distal advancement of the inner member 30″ may belimited, e.g., by an actuator on the proximal end (not shown) of theapparatus 10,″ such that the outlet 58″ is opened without excessivestretching of the balloon 50.″ For example, the apparatus 10″ mayinclude a handle or hub (not shown) on the proximal end of the outermember 20,″ and an actuator (also not shown) on the handle may bemovable for directing the apparatus 10″ between the open and closedpositions. Optionally, the actuator may be biased to one of thepositions, similar to the other embodiments herein.

Turning to FIGS. 5A-5C, exemplary methods are shown for treating a bodylumen 90, e.g., using the apparatus 10″ (or any of the other apparatusherein). The target body lumen 90 may be a blood vessel, e.g., a vein orartery, a graft, e.g., an aorto-venous fistula, tubular xenograft, orsynthetic tubular graft, and the like. For example, the body lumen 90may be a passage communicating between an adjacent artery and vein (notshown), e.g., in an arm or other region of a dialysis patient.Alternatively, the body lumen 90 may be a blood vessel within apatient's vasculature, e.g., a peripheral vessel in a patient's leg, acerebral vessel, and the like.

Optionally, the body lumen 90 may be accessed using one or moreadditional instruments (not shown), which may be part of a system or kitincluding the apparatus 10.″ For example, an introducer sheath, guidecatheter, or other tubular member (not shown) may be introduced adjacentthe target site, or may be introduced elsewhere in the patient's body toprovide access to the patient's vasculature or other passagescommunicating with the body lumen. If the body lumen 90 is located in aperipheral vessel of the patient, a percutaneous puncture or cut-downmay be created using a needle or other instrument (not shown) at aperipheral location, such as a femoral artery, carotid artery, or otherentry site (also not shown), and an introducer sheath may be placedthrough the puncture at the peripheral location to provide access. Theapparatus 10″ may be advanced through the patient's vasculature from theentry site, e.g., alone or with the aid of a guide catheter, guidewire,and the like (not shown).

For example, to facilitate directing the apparatus 10″ from an entrysite to the target body lumen 90, a guide catheter, micro-catheter, orother tubular body (not shown) may be placed from the entry site to thebody lumen 90 using conventional methods. In addition or alternatively,a guidewire 99″ may be placed from the entry site to the body lumen 90,as shown, e.g., if the inner member 30″ includes the second lumen 36″(not shown, see FIGS. 3-4B).

Turning to FIG. 5A, in a first exemplary method, the body lumen 90 mayinclude an occlusion 94, e.g., a chronic total occlusion within a bloodvessel, and the guidewire 99″ may be tracked from the entry site intothe body lumen 90 and through the occlusion 94, e.g., using knownmethods. Such lesions may be particularly difficult to treat becausethere is little opportunity to perform conventional dye injections tofacilitate imaging since there is no flow through the body lumen 90.Further, it may be difficult to track and/or position the guidewire 99″and/or apparatus 10″ within the body lumen 90 without using dyeinjections.

Initially, the apparatus 10″ may be advanced into the body lumen 90 withthe balloon 50″ in its collapsed condition. For example, the apparatus10″ may be advanced over the guidewire 99″ previously placed through theocclusion 94, e.g., until the distal end 54″ of the balloon 50″ entersthe region of the body lumen 90 beyond the occlusion 94, as shown.

With the distal end 54″ of the balloon 50″ beyond the occlusion 94 andthe valve open, radiopaque contrast, dye, or other fluid, represented by95, may be delivered into the body lumen 90 via the annular passagedefined by the first lumen between the outer and inner members 20,″ 30″to facilitate locating and/or measuring the size of the material of theocclusion 94 and/or body lumen 90, e.g., using fluoroscopy. Markers (notshown) on the apparatus 10″ may facilitate positioning the balloon 50″relative to the occlusion 94 before the balloon 50 is expanded, e.g., tofacilitate verifying that the balloon 50″ is positioned through and/oracross the occlusion 94. If desired, the inner member 30″ may bedirected back and forth between the first and second positions, e.g., toallow infusion of contrast and to reduce the profile of the apparatus10″ to facilitate further advancement, e.g., until the balloon 50″ islocated beyond the occlusion 94.

Thus, the apparatus 10″ may facilitate dye injection beyond theocclusion 94 while maintaining the guidewire 99″ in position. Unlike theapparatus 10,″ conventional devices may require removing a guidewire orother device advanced through the occlusion 94 to allow dye injectionsand imaging beyond the occlusion 94. In such procedures, it may bedifficult to reintroduce the guidewire or other device back through thesmall passage created through the occlusion 94.

With continued reference to FIG. 5A, once the apparatus 10″ ispositioned with the balloon 50″ across the occlusion 94, the valve maybe closed and the balloon 50″ may be inflated within the body lumen 90,e.g., to dilate or otherwise treat the occlusion 94. Optionally, asshown in FIG. 5B, a stent 96″ may be carried by the balloon 50″ and maybe expanded by inflating the balloon 50.″ For example, with the valve ofthe apparatus 10″ open, dye 95 may be injected into the body lumen 90 tofacilitate imaging and positioning the apparatus 10.″ Once the stent 96″is positioned across the occlusion 94, the valve may be closed, and theballoon 50″ inflated to expand the stent 96″ and dilate the occlusion 94(not shown). Once the stent 96″ is expanded, the balloon 50″ may becollapsed and the apparatus 10″ removed from the body lumen 90 andpatient's body.

If desired, the obstructive material may be treated, e.g., at leastpartially dissolved, macerated, and the like before, during, or afterwithdrawal. For example, a therapeutic agent may be delivered into thebody lumen 90 via the first lumen of the outer member 20,″ e.g., to atleast partially dissolve or separate thrombus or other relatively softmaterial before being dilated by the balloon 50″ and/or stent 96.″

Turning to FIG. 5C, in another method, the apparatus 10″ may be used asa drug delivery platform for treating the occlusion 94. For example, insome applications, it may be desirable to deliver an anti-restenosisdrug without a stent. As shown, the apparatus 10″ includes a carrier 98″provided over the balloon 50″ that may be delivered into the body lumen90 and/or through the occlusion 94.″ For example, as described above,the apparatus 10″ may be advanced into the body lumen 90 with theballoon 50″ and the carrier 98″ thereon in a collapsed condition, e.g.,over the guidewire 99.″

With the distal end 54″ of the balloon 50″ beyond the occlusion 94 andthe valve open, contrast, dye, or other fluid 95 may be delivered intothe body lumen 90 to facilitate locating and/or measuring the size ofthe occlusion 94 and/or body lumen 90, e.g., using fluoroscopy. Once theapparatus 10″ is positioned with the balloon 50″ across the occlusion94, the valve may be closed and the balloon 50″ inflated within the bodylumen 90 to dilate the occlusion 94 and deliver the carrier 98.″ Oncethe carrier 98″ is delivered, the balloon 50″ may be collapsed and theapparatus 10″ removed from the body lumen 90 and patient's body. One ormore therapeutic agents may be positioned within or otherwise carried bythe carrier 98″ and, therefore, may remain within the dilated occlusion94 to treat the body lumen 90.

Alternatively, the agent(s) may be delivered directly from the wall ofthe balloon 50.″ For example, the agent(s) may be infused through thewall of the balloon 50,″ e.g., by providing a porous layer on theballoon 50″ into which the agent(s) may be embedded or otherwise placed.

In another alternative, the agent delivered into the body lumen 90 maybe provided from multiple components that may react or interact in situonce delivered together within the body lumen 90. For example, a firstcomponent (or one or more additional components less than all componentsof the agent) may be carried on the wall of the balloon 50,″ e.g., in aporous layer or on a carrier 98″ disposed around the balloon 50,″ asdescribed above. The second component (or multiple remaining componentsneeded for the agent) may be delivered via the outlet 58″ on theapparatus 10.″ For example, after one or more components are deliveredby closing the valve and inflating the balloon 50″ within the occlusion94, the valve may be opened and a fluid carrying the one or moreremaining components may be delivered into the body lumen 90. Thecomponents may then combine to form an active drug or agent that maytreat the material of the occlusion 94 and/or otherwise treat the bodylumen 90.

Turning to FIG. 7, another embodiment of an apparatus 110 is shown fortreating a body lumen that generally includes an outer tubular member120, an inner member 130, and an expandable balloon 150 carried by theinner and/or outer members 120, 130, similar to other embodimentsherein. The apparatus 110 may be operable in a first mode for infusingfluid into a body lumen, a second mode for dilating an obstructionwithin a body lumen, and/or a third mode for removing obstructivematerial within a body lumen, as described further below.

As shown, the outer member 120 includes a proximal end 122, a distal end124 sized for introduction into a body lumen, and a first lumen 126extending between the proximal and distal ends 122, 124, which may beconstructed similar to other embodiments herein. The inner member 130also includes a proximal end 132, a distal end 134, and, optionally, asecond lumen 136 extending between the proximal and distal ends 132,134, e.g., sized to slidably receive a guide wire, or other rail (notshown) therethrough. The inner member 130 is sized to be slidablyreceived within the first lumen 126 of the outer member 120, e.g., suchthat an annular space is defined between the outer and inner members120, 130 for passing one or more fluids therethrough, also similar toother embodiments herein.

The balloon 150 includes a proximal end 152 coupled to the outer memberdistal end 124, a distal end 154 defining an outlet 158, and an interior156 communicating with the first lumen 126 and the outlet 158. Thedistal end 134 of the inner member 130 may extend through the distal end154 of the balloon 150, e.g., such that the outlet 158 defines anannular passage between the distal end 154 of the balloon 150 and thedistal end 134 of the inner member 130. As shown, the distal end 154 ofthe balloon 150 may include a collar or sleeve 155 attached or otherwisesecured to the distal end 154, e.g., by bonding with adhesive,interference fit, sonic welding, fusing, and the like. Optionally, thecollar 155 may extend proximally into the interior 156 of the balloon150 (not shown) and the interior section of the collar 155 may includeone or more side ports or other openings (also not shown), e.g., tofacilitate fluid passing from the balloon interior 156 through theoutlet 158. Alternatively, the distal end 154 of the balloon 150 may beintegrally formed with the balloon 150 from similar or dissimilarmaterials as the main portion of the balloon 150 and/or may includeother features (not shown), e.g., similar to other embodiments herein.

The balloon 150 may be formed from substantially inelastic material,e.g., to provide a non-compliant balloon that expands to a predeterminedsize when inflated independent of pressure (once a minimum volume isintroduced to achieve the predetermined size). Such a non-compliantballoon 150 may expand to the predetermined size even if inflated torelatively high pressures, e.g., until the balloon 150 bursts orotherwise ruptures, e.g., at pressures of at least ten atmospheres,twenty atmospheres, thirty atmospheres, and the like. Alternatively, theballoon 150 may be formed from elastic material, similar to otherembodiments described elsewhere herein.

One or more sealing members 138 may be carried on the inner memberdistal end 134, e.g., such that the sealing member(s) 138 are movablerelative to the balloon 150 as the inner member 130 is moved, e.g., toprovide a valve for selectively opening and closing the outlet 158 ofthe balloon 150. As shown, a first sealing member 138 is provided on theinner member 130 distal to the balloon distal end 154 and collar 155.The sealing member 138 may have a size, e.g., outer diameter, that islarger than the collar 155 and/or the distal end 154 of the balloon 150such that the sealing member 138 may substantially engage the collar 155and/or distal end 154 of the balloon 150 to substantially seal theoutlet 158.

In the exemplary embodiment shown, the sealing member 138 may include atapered shape, e.g., on one or both of its proximal and distal ends toprovide a nosecone on the inner member 130. For example, a tapered shapeon the proximal end of the sealing member 138 may automatically guidethe sealing member 138 into being seated in the outlet 158 of theballoon 150, e.g., to enhance a fluid-tight seal therebetween. A taperedshape on the distal end of the sealing member 138 may provide a roundedor otherwise substantially atraumatic tip for the apparatus 110. Inaddition or alternatively, other substantially atraumatic distal tips(not shown) may be provided on the inner member 130 beyond the firstsealing member 138, similar to other embodiments herein, e.g., a “J”shaped tip, as shown in FIGS. 33A and 33B, a beveled tip, as shown inFIG. 32, a threaded tip, and the like (not shown).

With continued reference to FIG. 7, a handle or hub 160 may be coupledto or otherwise provided on the proximal end 122 of the outer member120, e.g., for manipulating the outer member 120 and/or the entireapparatus 110, generally similar to the other embodiments herein. Thehandle 160 may include a pull handle 162 or other actuator coupled tothe inner member 130 for moving the inner member 130 to the variouspositions described below. The handle 160 may also include one or moreports, such as side port 164 for coupling one or more fluid sources tothe apparatus 110, e.g., a syringe or other source of fluid fordelivering fluid through the first lumen 126 into the interior 156 ofthe balloon 150 and/or through the outlet 158, depending upon theposition of the inner member 130.

Optionally, the handle 160 may include one or more seals, bushings, andthe like, such as o-ring 166, between the outer and inner members 120,130, which may guide the inner member 130 as it moves axially relativeto the outer member 130 and handle 160. In this embodiment, the innermember 130 includes a section of hypotube or other substantially rigidtubing 131 attached or otherwise coupled to the proximal end 132 of theinner member 130. The tubing 131 may provide axial support for the innermember 130, e.g., to prevent buckling or kinking when the inner member130 is directed axially. The tubing 131 may also allow the inner member130 to move axially more easily, e.g., if the tubing 131 has asubstantially smooth or lubricated outer surface that slides easilythrough the o-ring 166 while maintaining a fluid-tight sealtherebetween.

In addition or alternatively, if desired, the apparatus 110 may includeone or more markers to facilitate positioning and/or advancement of theapparatus 110 during use. For example, as shown in FIG. 7, radiopaquemarker bands 137 may be attached around the distal end 134 of the innermember 130, e.g., within the balloon interior 56. As shown, a marker 137is attached adjacent both the proximal end 152 and the distal end 154 ofthe balloon 150, which may facilitate monitoring the location of theballoon 150 before dilating an obstruction within a body lumen. Inaddition or alternatively, a core wire of the helical member 170 may beformed from radiopaque material, and/or radiopaque filler material,BASO4, may be dispersed into plastic material used to form the helicalmember 170, if desired.

Unlike the previous embodiments, the apparatus 110 includes a helicalmember 170 coupled between the outer and inner members 120, 130 withinthe balloon interior 156. The helical member 170 may be movable from arelatively low profile, such as that shown in FIG. 7, to an expandedhelical shape, as described further below. As shown, the helical member170 is a wire, tube, or other filament including a first end 172 coupledto the distal end 124 of the outer member 120 and a second end 174coupled to the distal end 134 of the inner member 130. For example, thehelical member 170 may be from a core wire having a tube or sleeveformed or attached around the wire (not shown). Alternatively, thehelical member 170 may be formed from multiple filaments (not shown)wound around one another or otherwise coupled together to act as aunitary structure. In exemplary embodiments, the helical member 170 maybe made from thermoplastic, thermoset, and/or other plastics, glass,metal, or composite materials.

Between the first and second ends 172, 174, the helical member 170 maywrap helically around the inner member 130 one or more times. As shown,the helical member 170 extends around the inner member 130 about one anda half turns, although it will be appreciated that the helical member170 may include more or fewer turns.

As shown, the first end 172 of the helical member 170 may be attached orotherwise secured directly to the distal end 124 of the outer member120, e.g., by one or more of bonding with adhesive, sonic welding,soldering, interference fit (e.g., by wrapping the first end 172 one ormore times around the distal end 124), inserting the first end 172 intoan annular groove, hole, or pocket (not shown) in the distal end 124,fusing, by an overlying band or collar (also not shown), and the like.The second end 174 of the helical member 170 may be similarly attachedor otherwise secured to a sleeve 178 fixed to the distal end 134 of theinner member 130 or directly to the distal end 134.

The sleeve 178 may be a relatively short tube attached to the innermember distal end 134 adjacent the balloon distal end 154, e.g., bybonding with adhesive, sonic welding, interference fit, fusing, and thelike. The sleeve 178 may have an outer diameter larger than the innerdiameter of the collar 155 and/or distal end 154 of the balloon 150,thereby providing a stop that limits movement of the collar 155 anddistal end 154 relative to the inner member 130. When the sleeve 178contacts the collar 155 and/or distal end 154, the sleeve 178 may notsubstantially obstruct the annular passage communicating with the outlet158, e.g., such that fluid may still flow through the outlet 158 whenintroduced into the balloon interior 156. Alternatively, the sleeve 178may be shaped to substantially seal the outlet 158 when the sleeve 178engages the collar 155 and/or distal end 154 of the balloon 150, similarto the other sealing members described elsewhere herein. Optionally,during manufacturing or assembly, the collar 155 may be positionedbetween the sealing member 138 and the sleeve 178 when the collar andsleeve 178 are attached to the inner member distal end 134, i.e., beforeattaching the collar 155 to the balloon distal end 154. The balloondistal end 154 may then be attached over the collar 155 when the balloon154 is attached to the outer member distal end 124. If desired, theballoon distal end 154 may be attached to the collar 155 such that aproximal section of the collar 155 is disposed within the interior 156of the balloon 150. If so, the proximal section of the collar 155 mayinclude one or more openings (not shown) to facilitate fluid passingfrom the balloon interior 156 through the collar 155 and out the outlet158, i.e., when the outlet 158 is not sealed by the sealing member 138,as described further below.

The inner member 130 may be movable axially relative to the outer member120, e.g., between a first or distal position, a second or intermediateposition (shown in FIG. 7), and/or a third or proximal position (notshown), thereby allowing the apparatus 110 to provide differentfunctions for treating a body lumen. For example, in the first position,the inner member 130 may direct the sealing member 138 distally suchthat the sealing member 138 is spaced apart from the balloon outlet 158.Thus, fluid introduced through the first lumen 126 of the outer member120 may pass through the balloon interior 156 and out the outlet 158,e.g., into the body lumen beyond the distal tip 35, similar to theprevious embodiments.

If desired, the inner member 130 may be directed proximally to a secondposition, such as that shown in FIG. 7, in which the sealing member 138engages the collar 155 and/or distal end 154 of the balloon 150, therebysubstantially sealing the outlet 158 from fluid flow therethrough. Thus,any fluid introduced through the first lumen 126 enters the ballooninterior 156 and may expand the balloon 150. In this mode, the balloon150 may be expanded to an elongate substantially cylindrical shape,e.g., having a substantially uniform diameter main portion betweentapered end portions. In the expanded condition, the main portion of theballoon 150 may have a length between about twenty and eightymillimeters (20-80 mm) and a diameter between about three and twelvemillimeters (3-12 mm). The balloon 150 may be used to dilate orotherwise apply substantial pressure to a wall of a body lumen, e.g.,for dilating a stenosis, lesion, or other obstruction, similar to themethod shown in FIGS. 9E-9G and described further below.

In addition or alternatively, after inflating the balloon 150 to dilatethe body lumen, a source of vacuum may be coupled to the side port 164and the balloon 150 collapsed to a contracted condition around thehelical member 170. Alternatively, if the balloon 150 has not beenpreviously inflated, it may not be necessary to collapse the balloon 150using vacuum since the balloon 150 may already be sufficiently collapsedor otherwise remain in the contracted condition.

The inner member 130 may then be directed proximally to the thirdposition, thereby directing the ends of the helical member 170 towardsone another. This causes the helical member 170 to expand radiallyoutwardly as it is compressed axially, thereby causing the balloon 150also to compress axially and expand radially into an expanded helicalshape around the helical member 170, e.g., as shown in FIGS. 9C and 9D.Optionally, the inner member 130 and/or handle 150 may include one ormore stops (not shown) that limit proximal movement of the inner member130 when compressing and expanding the balloon 150 and helical member170. For example, the stop(s) may allow the inner member 130 to bepulled until the balloon length is reduced to between about six andthirty millimeters (6-30 mm), thereby preventing overcompression of theballoon 150 and/or helical member 170.

In one embodiment, the helical member 170 may have sufficient rigiditythat the helical member 170 may simply buckle elastically from the lowprofile towards the helical shape as it is compressed axially. Thus, thehelical member 170 may expand without substantial plastic deformationsuch that the helical member 170 may be returned to its original lowprofile shape (and expanded and collapsed repeatedly, if desired).Alternatively, the helical member 170 may be biased to a predeterminedexpanded helical shape but may be constrained in the low profile, e.g.,by providing axial tension on the ends 172, 174 of the helical member170 when the inner member 130 is in the first or second positions. Asthe inner member 130 is directed towards the third position, the tensionmay be released, whereupon the helical member 170 may resiliently expandtowards the expanded helical shape.

In another alternative, the helical member may be integrally formed orotherwise coupled directly to the balloon 150, e.g., attached to,embedded within, or otherwise secured to the balloon wall (not shown)between the proximal and distal ends 152, 154. For example, as shown inFIGS. 7B and 7D, one or more helically shaped wires or fibers 157′(e.g., one shown in FIG. 7B, two shown in FIG. 7D) may be molded,embedded, or integrally formed in the wall of the balloon 150.′ As theballoon 150′ is compressed axially when the inner member 130 is movedtowards the third position, the fiber(s) 157′ may automatically bias theballoon 150′ towards the expanded helical shape. Alternatively, as shownin FIG. 7C, a fiber 157″ may be molded, embedded, or integrally formedin the wall of the balloon 150″ that includes a core wire or member159,″ e.g., a radiopaque material, a biased core wire, and the like. Infurther alternatives, FIGS. 7E-7H show alternate shapes and/orconfigurations for a fiber 157 _(e) to 157 _(h) or other stiffeningfeatures that may be molded, embedded, or otherwise integrally formed inthe wall of the balloon 150 _(e) to 150 _(h) and extend helicallybetween proximal and distal ends of the balloon 150 _(e) to 150 _(h).The fiber(s) and/or stiffening features may include one or more turnsbetween the proximal and distal ends of the balloon 150′, 150″, or 150_(e) to 150 _(h), e.g., one and a half, two, three, four, or more turns.In addition, any of the fibers and/or stiffening features included on aballoon may provide cutting edges or elements, e.g., that may be atleast partially embedded into a wall of a body lumen when the balloon150′, 150″, or 150 _(e) to 150 _(h) is inflated to dilate an obstructionin a body lumen.

Returning to FIG. 7, with the balloon 150 in the expanded helical shape,the entire apparatus 110 may be directed along a body lumen, e.g., toremove obstructive material including scraping, scrubbing, or otherwiseseparating adherent material from a wall of the body lumen, if desired,similar to the method shown in FIGS. 9A-9D and described further below.Thus, in this embodiment, a single balloon 150 may be used for bothdilation, e.g., using relatively high pressures, and for scraping,scrubbing, or otherwise removing obstructive material within a bodylumen.

Turning to FIGS. 23A and 23B, an apparatus 110′ is shown that isgenerally similar to the apparatus 110 of FIG. 7, except that theapparatus 110′ includes an alternative embodiment of a handle 760 on theproximal end 122′ of the outer member 120.′ Generally, the handle 760includes an outer housing 761 (shown in FIG. 23A), an inner carriage 765(shown in FIG. 23B) slidable axially within the housing 761, a rotaryknob 762 carried by the housing 761 and coupled to the carriage 765, anda hub 763 extending from the housing 761. It will be appreciated thatthe handle 760 (and the other handles described below and elsewhereherein) may be provided on any of the apparatus described herein, e.g.,that include actuators for opening and closing a valve on the apparatusand/or otherwise expanding and/or collapsing a helical member on theapparatus.

The housing 761 may include one or more pieces, e.g., one or more setsof mating halves or clamshells (not shown) that may be connectedtogether, e.g., along a longitudinal seam (also not shown) to providethe housing 761, e.g., secured together by mating connectors, bondingwith adhesive, sonic welding, fusing, and the like. The housing 761 mayinclude a slot, track, or other features (not shown) that allow thecarriage 765 to slide axially within the housing 761 without substantiallateral movement. The housing 761 and/or carriage 765 may include one ormore cooperating features, e.g., stops (not shown) within the housing761 that limit axial movement of the carriage 765 relative to thehousing 761, for example, to limit movement of the inner member 130′between the first position (for infusion from the outlet 158′) and thethird position (where the balloon 150′ is directed to an expandedhelical shape, not shown).

The housing 761 may include a side port 764, e.g., including a Luer lockor other connector, for connecting a source of fluid to the apparatus110.′ The side port 764 may communicate with a lumen extending throughthe outer member 120′ for delivering fluid into the interior of theballoon 150,′ similar to the previous embodiments.

The knob 762 may include an outer portion 762 a surrounding or otherwiseextending radially from the housing 761, e.g., including ridges or otherfeatures to facilitate rotation or other manipulation of the knob 762during use, and an inner stem 762 b that extends axially along a firstpassage 765 a within the carriage 765. The inner stem 762 b and thecarriage 765 may include cooperating features, e.g., helical threads 762c, that translate rotation of the knob 762 into axial movement of thecarriage 765. Thus, the knob 762 may be substantially fixed axiallyrelative to the housing 761 and freely rotatable about a longitudinalaxis of the apparatus 110.′

The proximal end 132′ of the inner member 130′ may pass freely throughthe inner stem 762 b and be fixed relative to the carriage 765. Forexample, the inner member proximal end 132′ may be secured to thecarriage 765 by fixing the proximal end 132′ in a second passage 765 badjacent to and/or communicating with the first passage 765 a, e.g., bybonding with adhesive, sonic welding, fusing, interference fit, matingconnectors (not shown), and the like. Thus, axial movement of the innermember 130′ may be coupled to movement of the carriage 765.

The hub 763 may include a hypotube or other tubular member 763 a and aLuer lock or other connector 763 b secured to one another and/or to theouter housing 761. For example, a proximal end of the tubular member 763a and/or the connector 763 b may be attached to a proximal end of thehousing 761, e.g., by bonding with adhesive, sonic welding, fusing,interference fit, mating connectors (not shown), and the like.

The tubular member 763 a may be slidably received in the second passage765 b such that the tubular member 763 a and connector 763 b remainsubstantially stationary relative to the housing 761 as the carriage 765is directed axially. One or more seals, e.g., o-ring 766, may beprovided within or around the second passage 765 b that allow thetubular member 763 a to slide therethrough while providing a fluid-tightseal that prevents fluid from leaking through the passages 765 a, 765 band out of the housing 761.

During use, the knob 762 may be rotated in a first direction, therebytranslating the inner member 130′ distally to the first position to openthe outlet 158.′ Thus, fluid delivered through the outer member 120′ maypass through the balloon 150′ and exit the outlet 158,′ as describedabove. The knob 762 may be rotated in a second opposite direction,thereby translating the inner member 130′ proximally to the secondposition, e.g., until the sealing member 138′ seals the outlet 158′ toallow balloon expansion, and/or further to the third position, e.g., toexpand the balloon 150′ to the expanded helical shape, also as describedabove. Optionally, the knob 762 and/or housing 761 may include visual,audible, or other indicators (not shown) that identify the direction torotate the knob 762 to achieve the desired position(s) and/or thatindicate when a particular position is achieved, e.g., by aligning anarrow (not shown) on the knob 762 with respective indicators (also notshown) that identify the first, second, and/or third positions.Otherwise, the apparatus 110′ may operate similar to the previousembodiments.

Turning to FIGS. 24A-24C, another embodiment of a handle 860 is shownthat includes an outer housing 861 with a side port 864 (shown in FIG.24A), an inner carriage 865 (shown in FIG. 24B) slidable axially withinthe housing 861, and a hub 863 extending from the housing 861, generallysimilar to the handle 760. For example, the housing 861 may include oneor more pieces, e.g., one or more sets of mating halves or clamshells(not shown) that may be connected together and may include a slot,track, or other features (not shown) that allows the carriage 865 toslide axially within the housing 861, e.g., without substantial lateralmovement. The housing 861 and/or carriage 865 may include one or morefeatures that limit axial movement of the carriage 865 relative to thehousing 861, e.g., to limit movement of the inner member 130′ betweenthe first position (for infusion from the outlet 158′), second position(for balloon inflation), and the third position (where the balloon 150′is directed to an expanded helical shape, not shown).

The proximal end 132′ of the inner member 130′ is substantially fixedrelative to the carriage 865, e.g., by fixing the proximal end 132′ in apassage 865 a adjacent to a distal end of the carriage 865, for example,by bonding with adhesive, sonic welding, fusing, interference fit,mating connectors (not shown), and the like. Thus, axial movement of theinner member 130′ may be coupled to movement of the carriage 865.

The hub 863 may include a hypotube or other tubular member 863 a and aLuer lock or other connector 863 b secured to one another and/or to theouter housing 861. For example, a proximal end of the tubular member 863a and/or the connector 863 b may be attached to a proximal end of thehousing 861, e.g., by bonding with adhesive, sonic welding, fusing,interference fit, mating connectors (not shown), and the like.

The tubular member 863 a may be slidably received in the passage 865 a,e.g., adjacent a proximal end of the carriage 865, such that the tubularmember 863 a and connector 863 b remain stationary relative to thehousing 861 (and inner member proximal end 132′) as the carriage 865 isdirected axially. With both the tubular member 863 a and inner memberproximal end 1323′ received in the passage 865 a, a guidewire or otherinstrument, backloaded through the inner member 130,′ may pass freelythrough the passage 865 a, tubular member 863 a, and out the connector863 b (or inserted through the connector 863 b into the inner member130′). One or more seals, e.g., o-ring 866, may be provided within oraround the passage 865 a that allow the tubular member 863 to slidetherethrough while providing a fluid-tight seal that prevents fluid fromleaking through the passage 865 a out of the housing 861.

Instead of a rotary knob 762, the handle 860 includes a push button 862carried by the housing 861 and coupled to the carriage 865. For example,the housing 861 may include an elongate slot 861 a and the push button862 may be slidable axially within the slot 861 a. Optionally, as shown,the slot 861 a may include one or more pockets or detents 861 b that maycapture the push button 862, e.g., to releasably secure the push button862, and consequently the carriage 865 and inner member 130,′ in one ormore positions.

Optionally, the housing 861 may include one or more visual indicators,e.g., for identifying the position of the inner member 132′ when thepush button 862 is received in a particular pocket 861 b. For example,as shown in FIG. 24C, the housing 861 may include numbers or othersymbols 861 c aligned with respective pockets (not shown) such that whenthe push button, in this embodiment, lever 862 is aligned with aparticular symbol 861 c, the user can confirm that the inner member 130′is in a respective particular position.

As best seen in FIG. 24B, the push button 862 may include a base 862 asubstantially fixed relative to the carriage 865 and a cap 862 bslidable laterally relative to the base 862 a. For example, the base 862a may be integrally molded or otherwise formed with the carriage 865 andthe cap 862 b may be attached to the base 862 a such that the cap 862 bmay be slid laterally, e.g., substantially perpendicular to thelongitudinal axis of the handle 860. For example, the cap 862 b may bebiased such that the cap 862 b may automatically slide into a pocket 861b with which the cap 862 b is aligned, yet the bias may be overcome tomove the cap 862 b out of the respective pocket 861 b into the slot 861a so that the cap 862 b may be slid axially into another pocket 861 b.For example, a spring or other biasing mechanism (not shown) may beprovided within the cap 862 b or housing 861 that may push the cap 862 blaterally from the base 862 a.

Alternatively, the entire push button 862 may be fixed relative to thecarriage 865, e.g., integrally molded or formed together, and the pushbutton 862 and carriage 865 may be pivoted about the longitudinal axisto allow the cap 862 b to be directed out of a particular pocket 861 b,directed axially along the slot 861 a, and released or otherwise placedin another pocket 861 b. In this alternative, a spring or other biasingmechanism (not shown) may bias the push button 862 and carriage 865 todirect the cap 862 b into any pocket 861 b with which the cap 862 b isaligned when the cap 862 b is released.

In an exemplary embodiment, the handle 860 may include three pockets 861b, e.g., one corresponding to the first position of the inner member130,′ one corresponding to the second position, and one corresponding tothe third position. Thus, to place the inner member 130′ in any of thefirst, second, or third positions, the cap 862 b may be directed out ofa pocket within which the cap 862 b is received, the push button 862 maybe slid axially along the slot 861 a, and released or otherwise directedinto the desired pocket 861 b. Alternatively, the handle 860 may includeonly one or two pockets 861 b, e.g., if the push button 862 is biasedaxially to one of the positions.

During use, the push button 862 may be directed axially in a firstdirection, e.g., distally to the indicator “R” in FIG. 24C, and releasedor captured in a corresponding pocket, thereby translating the innermember 130′ distally to the first position to open the outlet 158.′Thus, fluid delivered through the outer member 120′ may pass through theballoon 150′ and exit the outlet 158,′ as described above. The pushbutton 862 may be directed out of the pocket and directed axially, e.g.,proximally, to the indicator “N”, thereby translating the inner member130′ proximally to the second position, e.g., until the sealing member138′ seals the outlet 158′ to allow balloon expansion. In addition, ifdesired, the push member 872 may be directed out of the “N” pocket,axially within the slot 861 a, and released in the third pocket,corresponding to indicator “D,” thereby translating the inner member130′ to the third position, e.g., to expand the balloon 150′ to theexpanded helical shape, also as described above.

Turning to FIGS. 25A and 25B, still another embodiment of a handle 960is shown that includes an outer housing 961 including a side port 964(shown in FIG. 25A), a carriage (not shown) within the housing 961, anda hub 963 extending from the housing 961, generally similar to theprevious embodiments. The carriage may include a rack 965 (shown in FIG.25B) including a plurality of teeth 965 a spaced apart axially along therack 965.

The proximal end (not shown) of the inner member 130′ may besubstantially fixed relative to the carriage (not shown) such that axialmovement of the inner member 130′ is coupled to movement of the carriageand consequently to the rack 965, similar to the previous embodiments.

The hub 963 may include a hypotube or other tubular member (not shown)and a Luer lock or other connector 963 b secured to one another and/orto the outer housing 961, similar to the previous embodiments. Thetubular member may be slidably received in a passage in the carriage,e.g., such that the connector 963 b remains substantially stationaryrelative to the housing 961 (and inner member 130′) as the carriage isdirected axially.

In this embodiment, the actuator is a rotary wheel 962 rotatably mountedto the housing 961, as shown in FIG. 25A. The rotary wheel 962 includesan outer wheel 962 a including ridges or other features to facilitateengaging and/or rotating the rotary wheel 962, and a pinion 962 b thatextends into the housing 961. As best seen in FIG. 25B, teeth on thepinion 962 b may interlock with the teeth 965 a on the rack 965 suchthat rotation of the outer wheel 962 a causes the rack 965, andconsequently, the inner member 130,′ to move axially relative to thehousing 961 and outer member 120.′ Optionally, the housing 961 mayinclude one or more visual indicators, e.g., for identifying theposition of the inner member 132′ when the wheel 962 a is rotated to oneor more orientations, similar to the previous embodiments.

During use, the rotary wheel 962 may be rotated in a first direction,e.g., to translate the inner member 130′ distally to the first positionto open the outlet 158.′ When desired, the rotary wheel 962 may berotated in a second opposite direction to translate the inner member130′proximally to the second position and/or third position, e.g., toallow inflation of the balloon 150′ and/or expanding the balloon 150′ tothe expanded helical shape, similar to the previous embodiments. Oneadvantage of the rotary wheel 962 is that the ratio of the outer wheel962 a, pinion 962 b, and teeth 965 on the rack 965 may be designed toprovide a desired mechanical advantage and/or precision of movement ofthe inner member 130.′

Another embodiment of a handle 1060 is shown in FIGS. 26A and 26B thatmay be included in any of the apparatus shown herein. Similar to theprevious embodiments, the handle 1060 includes a housing 1061 includinga hub 1063 and a side port 1064. In this embodiment, the actuator is asqueeze button 1062 that may be depressed to direct the inner member130′ axially. e.g., from a first position to a second position, similarto the embodiments described elsewhere herein. Generally, when thesqueeze button 1062 is pressed inwardly, links 1062 a, 1062 b definingthe button 1062 are flattened out, thereby directing the proximal link1062 a proximally if the distal link 1062 b is fixed axially relative tothe housing 1061.

For example, a first end of the distal link 1062 b may be pivotallycoupled to the housing 1061 and a second end pivotally coupled to afirst end of the proximal link 1062. A second end of the proximal link1062 a may be slidable axially along the housing 861, e.g., within aslot or track (not shown). With the second end of the proximal link 1062a coupled to the inner member 130,′ e.g., by a cable or other linkage1062 c, as the squeeze button 1062 is pressed inwardly, the proximallink 1062 pulls the inner member 130,′ e.g., from a first position (withthe outlet 158′ open) to a second position (allowing the balloon 158′ tobe inflated and/or expanded to the expanded helical shape).

Optionally a cover (not shown) may be placed over the squeeze button1062 to protect the user from catching anything between the links 1062a, 1062 b. In addition or alternatively, the squeeze button 1062 may beprovided on the top of the housing 1061 (as shown), e.g., to allow auser to actuate the squeeze button 1062 with their thumb, or on thebottom of the housing 1061 (not shown), e.g., to allow a user to actuatethe squeeze button 1062 with their index finger. Optionally, the handle1060 may include one or more features (not shown) to allow the squeezebutton 1062 to be releasably secured at one or more positions before thelinks 1062 a, 1062 b are completely flattened, e.g., to allow the innermember 130′ to be translated and fixed in different positions, e.g.,successively in the second and third positions, similar to the previousembodiments.

Turning to FIG. 8, still another embodiment of an apparatus 210 is shownfor treating a body lumen that generally includes an outer tubularmember 220, an inner member 230, an expandable balloon 250, and helicalmember 270 carried by the inner and/or outer members 220, 230, similarto the previous embodiments, but does not include a valve for opening orclosing an outlet in the balloon, unlike the embodiment of FIG. 7. Theapparatus 110 may be operable in a first mode for dilating anobstruction within a body lumen, and/or a second mode for removingobstructive material within a body lumen, as described further below.

As shown, the outer member 220 includes proximal and distal ends 222,224, and a first lumen 226 extending therebetween, and the inner member230 also includes proximal and distal ends 232, 234, and a second lumen236 extending therebetween. The inner member 230 is sized to be slidablyreceived within the first lumen 226 of the outer member 220, e.g., suchthat an annular space is defined between the outer and inner members220, 230 for passing one or more fluids therethrough, also similar tothe previous embodiments.

A handle or hub 260 may be coupled to or otherwise provided on theproximal end 222 of the outer member 220, e.g., including a pull handleor other actuator 262 for moving the inner member 230 relative to theouter member 220, a side port 264 for coupling one or more fluid sourcesto the apparatus 210, and an o-ring or other seal 166 between the outerand inner members 220, 230, which may also be similar to the previousembodiments.

The balloon 250 includes a proximal end 252 coupled to the outer memberdistal end 224, a distal end 254 coupled to the inner member distal end234, e.g., attached by bonding with adhesive, interference fit, sonicwelding, fusing, and the like, similar to the previous embodiments. Theballoon 250 may be formed from substantially inelastic material, e.g.,to provide a non-compliant balloon that expands to a predetermined sizewhen inflated independent of pressure, or alternatively, the balloon 250may be formed from elastic material, similar to the other embodimentsdescribed elsewhere herein.

Also similar to the embodiment of FIG. 7, the helical member 270 may becoupled between the outer and inner members 220, 230. Thus, the helicalmember 270 may be movable from a relatively low profile, such as thatshown in FIG. 8, to an expanded helical shape, as described furtherbelow with reference to FIGS. 9A-9D. As shown in FIG. 8, a first end 272of the helical member 270 may be attached or otherwise secured directlyto the distal end 224 of the outer member 220 and a second end 274 ofthe helical member 270 may be attached or otherwise secured to thedistal end 234 of the inner member 230 adjacent the balloon distal end252.

During use, in the exemplary methods shown in FIGS. 9A-9G, the apparatus210 may be used for treating a body lumen 90, e.g., for removingobstructive material 92 and/or dilating an obstruction 94 within a bodylumen 90, e.g., as shown in FIG. 9A. Similar to the previousembodiments, the target body lumen 90 may be a blood vessel, e.g., avein or artery, a graft, e.g., an aorto-venous fistula, tubularxenograft, or synthetic tubular graft, and the like.

Optionally, the body lumen may be accessed using one or more additionalinstruments (not shown), which may be part of a system or kit includingthe apparatus 210, e.g., including one or more introducer sheaths, guidecatheters, and/or guidewires (not shown). For example, to facilitatedirecting the apparatus 210 from an entry site to the target body lumen,a guide catheter, micro-catheter, introducer sheath, or other tubularbody (not shown) may be placed from the entry site to the body lumen 90using conventional methods. In addition or alternatively, a guidewire(not shown) may be placed from the entry site to the body lumen 90 ifdesired.

Initially, with reference to FIG. 9B, the apparatus 210 may be advancedinto the body lumen 90 with the inner member 230 in the first or distalposition, e.g., such that the balloon 250 is substantially collapsed.Optionally, contrast or other fluid may be delivered into the body lumen90, e.g., via the second lumen 236 in the inner member 230 (not shown,see FIG. 8) or via a separate lumen (not shown) in the outer member 220.Markers (not shown) on the apparatus 10 may facilitate positioning theballoon 250 relative to the material 92 intended to be removed, e.g., toposition the balloon 250 beyond or otherwise adjacent the material 92.

Optionally, the apparatus 210 may be introduced through a guide catheteror other tubular member (not shown) that includes a lumen communicatingwith a source of vacuum. With the balloon 250 disposed beyond the guidecatheter, the source of vacuum may be activated to aspirate materialwithin the body lumen 90, e.g., as the material 92 is dislodged orotherwise removed by the balloon 250, as described below.

Turning to FIG. 9C, the inner member 230 may be directed proximallyrelative to the outer member 220, thereby causing the helical member 270and consequently the balloon 250 to expand towards the expanded helicalshape, as described above. As shown in FIG. 9D, the entire apparatus 210may then be retracted to remove the material 92, e.g., scraping,scrubbing, or otherwise separating material that may be adhered to awall of the body lumen 90. For example, the apparatus 210 may be pulledto remove the material 92 from the body lumen and into the lumen of theguide catheter, where the material 92 may be aspirated from thepatient's body. Alternatively, the material 92 may be released in amanner such that the material 92 may be metabolized naturally by thepatient's body.

If desired, the inner member 230 may be returned to the first positionto collapse the balloon 250, and the apparatus 210 moved to anotherlocation within the body lumen 90. The inner member 230 may be directedbetween the first and second positions as often as desired to expand theballoon 250 and separate or otherwise remove sufficient material 92.

Turning to FIG. 9E, with sufficient material 92 removed, a stenosis,lesion, or other obstruction 94 is identified within the body lumen 90.The apparatus 210 may be reintroduced or repositioned in the body lumen90 with the balloon 250 collapsed until the balloon 250 is positionedadjacent the obstruction 94, e.g., using fluoroscopy or other additionalimaging. Once properly positioned, as shown in FIG. 9F, the balloon 250may be inflated to dilate and/or otherwise treat the obstruction 94.Optionally, the balloon 250 may carry one or more diagnostic and/ortherapeutic agents, which may be delivered against and/or into theobstruction 94 using the balloon 2500. After sufficient treatment, theballoon may be deflated, and the apparatus 10 removed from the bodylumen 90, as shown in FIG. 9G.

Optionally, with any of the embodiments described herein, variousballoon configurations may be provided. For example, turning to FIG.10A, with additional reference to the apparatus 250 of FIG. 8, anexemplary cross-section of the apparatus 210, taken through the balloon250, is shown. FIG. 10A shows the helical member 270 wound around theinner member 230 and surrounded by the expanded balloon 250. Thus, boththe helical member 270 and the inner member 230 are disposed within theinterior 256 of the balloon 250. One of the disadvantages of such aballoon 250 is that the wall must be relatively thick since it isdifficult to predict which areas of the balloon wall are going tocontact and scrape along a wall of a target body lumen.

FIGS. 10B-10D show alternative embodiments of balloon or tubularconstructions that may be provided for any of the embodiments describedherein. These constructions may be provided for a balloon capable ofinflation or for a tubular member capable of expansion to an expandedhelical shape without being inflated. Exemplary embodiments of suchdevices are disclosed in U.S. Pat. No. 4,762,130, the entire disclosureof which is expressly incorporated by reference herein.

For example, as shown in FIG. 10B, a balloon or tubular member 250′ isshown that includes a first lumen 251′ that receives the inner member230 and a second lumen 253′ that receives the helical member 270therein. When the tubular member 250′ and helical member 270 arecompressed axially, the helical member 270 may expand radially outwardlyaway from the inner member 230, thereby directing surface region 280′radially outwardly away from the inner member 230 since the surfaceregion 280′ is furthest from the first lumen 251.′ Thus, because thesurface region 280′ is likely to contact the wall of the body lumen whenthe tubular member 250′ is expanded, the construction of the tubularwall may be varied to enhance scraping and/or other removal ofobstructive material. For example, features may be integrally molded orotherwise formed in the wall of the tubular member 250,′ e.g., thatextend helically around the tubular member 250′ adjacent the secondlumen 253.′

As shown in FIG. 10B, the surface region 280′ may include a plurality ofgrooves that provide edges 282′ that may facilitate scraping adherentmaterial from the wall of the target body lumen, e.g., by concentratingcontact forces with the wall of the body lumen. In addition, the tubularwall opposite the surface region 280′ may be relatively thin since thisarea of the wall is unlikely to contact the wall of the body lumen,which may allow an overall cross-section or profile of the tubularmember 250′ to be reduced. Alternatively, or in addition, if desired,different property materials may be used, e.g., harder elastomericmaterials with relatively thinner wall thickness for the surface region280′ or elsewhere on the tubular member 250.′

Turning to FIG. 10C, another embodiment of a tubular member 250″ isshown that includes ridges or protrusions 282″ along surface region 280″that will contact the wall of the body lumen when the tubular member250″ is expanded. In a further alternative, shown in FIG. 10D, a tubularmember 250′″ may be provided that includes a first lumen 251′″ havingconvolutions molded or otherwise formed into the tubular wall. Theconvolutions may increase the circumferential length of the tubularwall, and therefore allow the wall to stretch to a greater radialdimension, yet still direct the surface region 280′″ towards the wall ofa body lumen being treated.

Turning to FIG. 11, another embodiment of an apparatus 310 is shown thatincludes an outer member 320, an inner member 330, and an expandablemember 350 carried on distal ends 324, 334 of the outer and innermembers 320, 330, similar to the previous embodiments. Unlike theprevious embodiments, the expandable member 350 may not include aninterior coupled to a lumen extending through the outer member 320,i.e., the expandable member 350 may not be inflatable. However,alternatively, if desired, the apparatus 310 may include a lumen (notshown) extending through the outer member 320 and communicating with aninterior of the expandable member 350 for selectively inflating orcollapsing the expandable member 350. In addition, if desired, theapparatus 310 may include one or more sealing members or other valve(not shown) that may be opened or closed for selectively infusing fluidor inflating the expandable member 350, similar to the previousembodiments.

The expandable member 350 generally includes a proximal end 352 coupledto the outer member distal end 324 and a distal end 354 coupled to theinner member distal end 334, e.g., by bonding with adhesive, sonicwelding, fusing, interference fit, one or more bands or other connectors(not shown), and the like. In addition, the apparatus 310 includes ahelical member (not shown) that may also be coupled between the outermember and inner member distal ends 324, 334 and extend helically aroundthe inner member 330, e.g., within the interior of or otherwise carriedby the expandable member 350, similar to the previous embodiments.

For example, the helical member may be loose within the interior of theexpandable member 350. Alternatively, the helical member may be embeddedin or otherwise attached to the wall of the expandable member 350, e.g.,to an inner surface of the expandable member 350.

Unlike the previous embodiment, the helical member includes a first coilwithin a first region 350 a of the expandable member 350 and a secondcoil within a second region 350 b of the expandable member 350 havingdifferent properties. The first and second coils may be coupled to oneanother, e.g., integrally formed together as a single wire, filament,and the like, or may be formed as separate wires or filaments attachedto one another. Each coil includes a plurality of turns that extendhelically around the inner member 330, e.g., between the proximal anddistal ends 352, 354 of the expandable member 350.

The coils may be provided in a relatively low profile around the innermember 330, e.g., when the inner member 330 is extended distallyrelative to the outer member 320 to a first position. When the innermember 330 is retracted proximally from the first position towards asecond position, the coils may be compressed axially, thereby causingthe coils to expand radially outwardly and expand the expandable member350 radially outwardly to an expanded helical shape, similar to theprevious embodiments.

The coils may have different mechanical properties from one another,thereby causing the first and second regions 350 a, 350 b of theexpandable member 350 to expand to different sizes and/or shapes in theexpanded helical shape. For example, as shown in FIG. 11, the firstregion 350 a may be expanded to a smaller diameter than the secondregion 350 b. This may be achieved by forming the first coil fromthinner, narrower, or otherwise more flexible material than the secondcoil. In addition or alternatively, the coils may be biased to differentdiameters such that when the inner member 330 is in the distal or firstposition, the coils may be constrained in the low profile, and when theinner member 330 is directed proximally towards the second position, thecoils may resiliently expand radially outwardly to the diameters setinto the coil material.

In addition or alternatively, the coils may be expandable sequentially,e.g., such that the first region 350 a of the expandable member 350 mayexpand to the expanded helical shape before the second region 350 b. Forexample, the first coil in the first region 350 a may have lessresistance to expansion than the second coil in the second region 350 b,e.g., by forming the first coil from thinner, narrower, and/or otherwisemore flexible material than the second coil. For example, the first coilmay include a bare wire wound helically around the inner member 330,while the second coil may include the same or different wire wrapped ina section of tubing, a sleeve, and the like, which may increaseresistance to expansion. Thus, when the inner member 330 is directedfrom the first position towards the second position, the compressiveforce may be applied initially to the first coil, thereby expanding thefirst coil and the first region 350 a of the expandable member 350,until a predetermined threshold is achieved, whereupon the second coilmay expand and expand the second region 350 b of the expandable member350.

In another alternative, a sleeve (not shown) attached to the innermember 330 may initially surround the second coil in the first positionsuch that only the first coil is free to expand when initiallycompressed. When the inner member 330 is directed towards the secondposition, the second coil may become exposed from the sleeve, and thenexpand radially outwardly to the expanded helical shape.

Turning to FIGS. 12 and 13, an exemplary method is shown for treating abody lumen, e.g., a arterio-venous dialysis graft 190, using theapparatus 310 of FIG. 11. As shown, the graft 190 includes a first orvenous anastomosis 192 attached to a vein 193 within a patient's body,e.g., within the patient's arm, and a second or arterial anastomosis 194attached to an artery 195 adjacent the vein 193. As shown, the graft 190includes obstructive material 92, e.g., thrombus, plaque, and the likeat multiple locations in the graft 190 including within each anastomosis192, 194.

Initially, an introducer or guide sheath 380 may be placed within thegraft 190, e.g., percutaneously through the patient's skin into acentral region of the graft 190, using similar methods to thosedescribed elsewhere herein. The sheath 380 may include a distal end 382having a size and/or shape for introduction into the graft 190 and aballoon 382 on the distal end 384 for substantially engaging a wall ofthe graft 190, e.g., to stabilize the sheath 380 relative to the graft190 and/or to substantially seal the graft 190 from fluid flow betweenthe ends 192, 194 of the graft 190. The sheath 380 may also include areservoir 386 communicating with a lumen extending to an opening (notshown) in the distal end 382, and a source of vacuum 388, e.g., asyringe, for applying a vacuum to aspirate material from within thegraft 190 during treatment.

The apparatus 310 may be introduced through the sheath 380 into thegraft 190 with the expandable member 350 initially in a contractedcondition. As shown in FIG. 12, the apparatus 310 may be advanced untilthe expandable member 350 is disposed distally beyond obstructivematerial 92 within the venous side of the graft 190, whereupon the innermember 330 (not shown) may be directed proximally to expand theexpandable member 350 to the expanded helical shape. As shown, bothcoils have been expanded, thereby expanding both the first and secondregions 350 a, 350 b of the expandable member 350, e.g., such that thesecond region 350 b may substantially engage or otherwise contact thewall of the graft 190.

The apparatus 310 may then be withdrawn to scrape or otherwise separateadherent material 92 from the wall of the graft 190 and pull thematerial 92 towards the sheath 380. The source of vacuum 388 may beactivated, if not already, to aspirate the material 92 through thesheath 380 into the reservoir 386. If desired, the inner member 330 maybe advanced to collapse the expandable member 350 back towards thecontracted condition and advanced further into the graft 190, e.g., torepeat the process of expanding the expandable member 350 to scrape orotherwise remove material 92.

Optionally, the sheath 380 may be repositioned within the graft 190towards the arterial anastomosis 194, and the apparatus 310 reintroducedwith the expandable member 350 in the contracted condition, e.g., toremove material 92 within the arterial side of the graft 190. Turning toFIG. 13, although material has been removed from the graft 190,additional obstructive material 92 remains within the arterialanastomosis 194. Because the anastomosis 194 communicates with theartery 195, care should be taken to ensure that material is not releasedinto the artery 195, where the material may flow into tissue beds, causeischemia, or other damage to tissue downstream of the artery 195.

The apparatus 310 may be advanced until the distal end 334 of the innermember 330 passes through material 92 within the arterial anastomosis194 with the expandable member 350 in the contracted condition. At thispoint, the inner member 330 may be directed proximally sufficientdistance to expand the first region 350 a of the expandable member 350without substantially expanding the second region 350 b. The apparatus310 may then be withdrawn to pull the expandable member 350 back towardsthe sheath 380, where any material 92 removed from the anastomosis 194may be aspirated out of the graft 190. Thus, the smaller first region350 b may allow greater care to be used to remove material fromsensitive regions, while the second region 350 b may be expanded withinrelatively large body lumens or otherwise when it is desired to applygreater force and/or remove greater amounts of material.

Turning to FIG. 14, an alternative embodiment of the apparatus 310 shownin FIG. 11 is shown. The apparatus 310′ of FIG. 14 is generally the sameas apparatus 310, e.g., including an outer member 320,′ an inner member330,′ an expandable member 350,′ and first and second coils defining ahelical member within the expandable member 350,′ similar to theprevious embodiments. Unlike the previous embodiment, the apparatus 310′includes a dilation balloon 359,′ e.g., a substantially non-compliant,high pressure balloon, on the outer member distal end 324.′ In addition,the apparatus 310′ includes a handle 360′ that includes a side port 364′to which a source of inflation media and/or vacuum 368′ may beconnected.

The apparatus 310′ may be used similar to the apparatus 310 shown inFIG. 11, e.g., using the methods of FIGS. 12 and 13. In addition, thedilation balloon 359′ may be positioned within a stenosis, lesion, orother obstruction, e.g., in the graft 190 of FIGS. 12 and 13, or withinother body lumens. The balloon 359′ may then be inflated or otherwiseexpanded to dilate the body lumen, similar to other embodimentsdescribed above. Optionally, a stent or other prosthesis (not shown) maybe carried by the balloon 359,′ e.g., such that the prosthesis may beimplanted within a body lumen after using the balloon 350′ to removeobstructive material from the body lumen. Alternatively, a stent orother prosthesis may be carried and delivered using any of the otherembodiments described herein, e.g., on the balloon 150 or 250 of theapparatus 110 or 210, shown in FIG. 7 or 8.

In another option, shown in FIG. 14A, an apparatus 310″ may be providedthat is generally similar to the apparatus 310′ of FIG. 14. Unlike theapparatus 310,′ the apparatus 310″ also includes an outer sheath 380″ atleast partially surrounding the outer member 320.″ For example, asshown, the outer sheath 380″ may include a proximal end 382″ attached tothe handle or otherwise disposed around the proximal end 322″ of theouter member 320″ and a distal end 384″ extending distally to a locationadjacent the distal end 324″ of the outer member 320,″ e.g., proximal toballoon 359.″ The outer sheath 380″ may have a diameter or othercross-section larger than the outer member 322″ such that an annularlumen 386″ is provided between the outer sheath 380″ and the outermember 320.″ The lumen 386″ may communicate with a side port 365 a″ onthe handle 360,″ which may include a Luer fitting or other connector.Thus, a syringe or other source of vacuum (not shown, e.g., similar tosyringe 368″) may be coupled to the side port 365 a″ and used toaspirate material adjacent the balloon 359″ through the lumen 386.″ Inaddition or alternatively, a source of lytic agent and/or one or moreother agents (also not shown) may be coupled to the side port 365 a″ andthe agent(s) may be delivered through the annular lumen 386″ into thebody lumen instead of or in conjunction with aspiration.

In addition, the apparatus 310″ includes an annular balloon or otherexpandable member 388″ on the distal end distal end 384″ of the outersheath 380.″ The outer sheath 380″ may include an inflation lumen (notshown), e.g., extending proximally along the wall of the outer sheath380″ to the proximal end 382,″ and communicating with another side port365 b,″ which may include a Luer fitting or other connector, similar tothe side port 365 a″ to which a syringe or other source of inflationmedia (not shown, e.g., similar to the syringe 368″) may be coupled.

During use, the outer sheath 380″ may be provided around the outermember 320″ when the apparatus 310″ is introduced into a body lumen,e.g., similar to other embodiments herein. Optionally, the distal end384″ of the outer sheath 380″ may be tethered or otherwise coupled tothe outer sheath 380′″ to prevent proximal migration of the distal end384″ during advancement of the apparatus 310.″ In addition oralternatively, the annular balloon 388″ may have a collapsedconfiguration that frictionally and/or otherwise engages the outermember 320″ to prevent migration of the distal end 384″ of the outersheath 380.″

Once the apparatus 310″ is positioned within a body lumen (not shown)being treated, e.g., by the balloon 350″ and/or balloon 359,″ theannular balloon 388″ may be expanded, e.g., to engage the surroundingwall of the body lumen and/or to open the distal end 384″ of the outersheath 380.″ The annular balloon 350″ may be formed from elasticmaterial and/or inelastic material, e.g., that allows the annularballoon 350″ to radially expand and substantially engage the surroundingwall to provide a seal, e.g., that may stop substantially all flowthrough the body lumen or simply prevent substantial migration of loosematerial within the body lumen. At any time, vacuum may be applied tothe annular lumen 386″ of the outer sheath 380,″ e.g., to aspirate orotherwise remove material separated from the wall of the body lumen (notshown) through the lumen 386.″

Optionally, the outer sheath 380″ may be formed from substantiallyflexible material, e.g., to allow the outer sheath 380″ to be compressedand/or extended axially, e.g., if the apparatus 310″ is moved axiallyand/or radially while the annular balloon 380″ is engaged with the wallof body lumen. Thus, material separated from the wall of the body lumenmay be directed towards the annular lumen 386,″ e.g., using the balloon350″ or 359″ and aspirated through the annular lumen 386″ from the bodylumen.

Alternatively, if the outer sheath 380′″ has a substantially fixedlength, the annular balloon 380″ may be include lubricious material thatallows the balloon 380″ to slide along the wall of the body lumen whenthe apparatus 310″ is directed axially while maintaining a seal with thewall to reduce the risk of loose material within the body lumen fromescaping and traveling to other locations within the patient's body. Inthis alternative, the aspiration vacuum may be sufficient to draw loosematerial from the body lumen without pushing the material towards theannular lumen with one of the balloons 350,″ 359.″

In another alternative, at least the distal end 384″ of the outer sheath380″ may be radially expandable, e.g., such that the outer sheath 380″may be provided in a collapsed configuration around the outer member320,″ e.g., during introduction of the apparatus 310,″ yet may beexpanded to open the annular lumen 386″ to allow material to beaspirated from the body lumen through the annular lumen 386.″ In thisalternative, the annular balloon 380″ may be omitted. It will beappreciated that an outer sheath and/or annular balloon may be providedon other embodiments herein, e.g., to facilitate aspiration of materialand/or reduce the risk of migration of material released within a bodylumen during treatment.

Turning to FIGS. 15A and 15B, exemplary embodiments of coils are shownthat may be included in any of the apparatus described herein includinga helical member for expanding a balloon or other expandable member toan expanded helical shape. For example, FIG. 15A shows a coil 370 thatincludes substantially smooth, uniform turns 372 that may beincorporated as a helical member in any of the apparatus describedabove. Alternatively, as shown in FIG. 15B, a coil 370′ may be providedthat includes a plurality of turns 372′ having alternating high points374′ and low points 376′ that may increase contact force with a wall ofa body lumen when the coil 370′ is included within a balloon orexpandable member (not shown), such as those described elsewhere herein.The high and low points 374,′ 376′ may be staggered between adjacentturns, e.g., to ensure that at least some high points 374′ contactand/or scrape along substantially the entire circumference of a wall ofa target body lumen.

Turning to FIG. 16, still another embodiment of an apparatus 410 isshown that includes multiple expandable devices on a single shaft, e.g.,such that the apparatus 410 may be operable in multiple modes, e.g., afirst mode for removing material within a body lumen, and a second modefor dilating an obstruction within a body lumen.

Generally, the apparatus 410 includes an outer member 420, an innermember 430, a handle 460, and a first balloon or other expandable member450 carried by the outer and inner members 420, 430, similar to theprevious embodiments. The outer member 420 includes proximal and distalends 422, 424, and a first lumen 426 extending therebetween, and theinner member 430 also includes proximal and distal ends 432, 434, and asecond lumen 436 extending therebetween.

The first balloon 450 includes a proximal end 452 coupled to the outermember distal end 424 and a distal end coupled to the inner memberdistal end 434, and includes an interior communicating with the firstlumen 426. The first balloon 450 may be formed from elastic material,e.g., such that the first balloon 450 may be expanded to a range ofdiameters and/or shapes, e.g., depending upon the volume of inflationmedia delivered into the interior of the first balloon 450 and/or theposition of the inner member 430 relative to the outer member 420.

In addition, a second balloon 459 may be provided on the outer member420, e.g., proximal to the first balloon 450. The second balloon 459 maybe formed from substantially inelastic material, e.g., to provide anon-compliant, high pressure dilation balloon, similar to otherembodiments described elsewhere herein. The outer member 420 includes athird inflation lumen 465 communicating with the interior of the secondballoon 459.

As shown, the handle 460 includes a first side port 464 a communicatingwith the first lumen 426 for delivering inflation media into the firstballoon 450, and a second side port 464 b communicating with the thirdinflation lumen 465 for delivering inflation media into the secondballoon 459. In addition, the handle 460 may include a pull handle orother actuator 462 for directing the inner member 430 to one or moreaxial positions relative to the outer member 420, and one or more seals,e.g., o-ring 466 for sealing the first lumen 426, similar to theprevious embodiments.

Turning to FIGS. 17A-17D, the apparatus 410 is shown in different modeswith the inner member 430 in respective positions. First, as shown inFIG. 17A, the inner member 430 is in a first or distal position with thefirst and second balloons 450, 459 in contracted conditions. In thisconfiguration, the apparatus 410 may be introduced into a patient'sbody, into a target body lumen being treated, similar to the previousembodiments.

Turning to FIG. 17B, the first balloon 450 has been inflated to anexpanded condition with the inner member remaining in the firstposition. Thus, the first balloon 450 may be expanded to one or morediameters, e.g., to engage or contact the wall of a body lumen beingtreated. The apparatus 410 may then be retracted or otherwise directedaxially to scrape the first balloon 450 along the wall, e.g., to removethrombus or other adherent material from the wall. Optionally, as shownin FIG. 17C, if greater pressure is desired, or a larger balloon isdesired due to the size of the body lumen, the pull handle 462 may bedirected proximally to pull the inner member 430 proximally relative tothe outer member 420, thereby axially compressing and radially expandingthe first balloon 450.

Finally, as shown in FIG. 17D, if it desired to dilate a stenosis,lesion, or other obstruction, the first balloon 450 may be collapsed tothe contracted condition, and the second balloon 459 may be positionedadjacent the obstruction and inflated to expand and dilate theobstruction, similar to the previous embodiments. Thus, the apparatus410 may be used for different treatments, e.g., embolectomy and/orangioplasty, without having to remove the apparatus 410, similar to theprevious embodiments. The apparatus 410 may be tracked over a guidewireor other rail received through the second lumen 436 of the inner member430, which may facilitate directing the apparatus 410 to variouspositions within a body lumen during treatment.

Turning to FIGS. 18A-18C, another embodiment of an apparatus 610 isshown for treating a body lumen that includes an outer tubular member620, an inner member 630, and an expandable balloon 650 carried by theinner and/or outer members 620, 630, generally similar to the previousembodiments. In addition, as shown in FIGS. 19A-19C, the apparatus 610may include a handle or hub 660 coupled to or otherwise provided on aproximal end 622 of the outer member 620, e.g., for manipulating theouter member 620 and/or the entire apparatus 610, generally similar tothe previous embodiments. Also similar to previous embodiments, theapparatus 610 may be operable in multiple modes, e.g., a first mode fordilating an obstruction within a body lumen (FIGS. 18A, 19A), a secondmode for infusing fluid into a body lumen (FIGS. 18B, 19B), and/or athird mode for removing obstructive material within a body lumen (FIGS.18C, 19C), as described further below.

As shown, the outer member 620 includes a proximal end 622, a distal end624 sized for introduction into a body lumen, and a first lumen 626extending along a central longitudinal axis 627 therebetween, which maybe constructed similar to the previous embodiments. The inner member 630also includes a proximal end 632, a distal end 634, and, optionally, asecond lumen 636 extending between the proximal and distal ends 632,634, e.g., sized to slidably receive a guidewire, or other rail (notshown) therethrough. The inner member 630 is sized to be slidablyreceived within the first lumen 626 of the outer member 620, e.g., suchthat an annular space is defined between the outer and inner members620, 630 for passing one or more fluids therethrough, also similar tothe previous embodiments. One or more sealing members, e.g., a nosecone638, may be provided on the distal end 634 of the inner member 630, alsosimilar to the previous embodiments.

As best seen in FIG. 18A, the balloon 650 includes a proximal end 652coupled to the outer member distal end 624, a distal end 654 defining anoutlet 658, and an interior 656 communicating with the first lumen 626and the outlet 658. The distal end 634 of the inner member 630 mayextend through the distal end 654 of the balloon 650, e.g., such thatthe outlet 658 defines an annular passage between the distal end 654 ofthe balloon 650 and the distal end 634 of the inner member 630. As bestseen in FIG. 18B, the distal end 654 of the balloon 650 includes aspring stop, e.g., a collar or sleeve 655, attached or otherwise securedwithin the distal end 654, e.g., by bonding with adhesive, interferencefit, sonic welding, fusing, and the like. The spring stop 655 may bespaced proximally from the outlet 658, e.g., such that the spring stop655 does not interfere substantially with fluid flowing through theoutlet 658 when the nosecone 638 is directed away from the outlet 658,as described further elsewhere herein.

Optionally, the distal end 654 of the balloon 650 may include a coatingor other liner 657, e.g., adjacent the spring stop 655. For example, theliner 657 may include a lubricious and/or low surface energy material,e.g., PTFE, applied to the interior portion of the distal end 654 of theballoon 650 that may contact the nosecone 638, e.g., to reduce frictionand/or adhesion between the balloon 650 and the nosecone 638, asdescribed further below. Alternatively, the distal end 654 may beconstructed similar to other embodiments herein, such as the embodimentsshown in and described with respect to FIGS. 31A-32B.

The balloon 650 may be formed using similar materials and methods to anyof the other embodiments described herein, for example, fromsubstantially inelastic material, e.g., to provide a non-compliantballoon that expands to a predetermined size when inflated independentof pressure. The nosecone 638 may be carried on the inner member distalend 634 such that the nosecone 638 is movable relative to the balloon650 as the inner member 630 is moved, e.g., to provide a valve forselectively opening and closing the outlet 658 of the balloon 650. Theliner 657 may slidably contact the balloon 650, e.g., when the apparatus610 is in the first position shown in FIG. 18A, such that asubstantially fluid-tight seal is created without substantial frictionor resistance to separation of the nosecone 638, e.g., when the outlet658 is opened. For example, if the apparatus 610 is positioned in thefirst position after manufacturing and/or assembly, the liner 657 andnosecone 638 may remain in contact with one another for an indefinitetime, e.g., during packaging, shipping, and/or storage, before use. Theliner 657 may reduce the risk of adhesion between the balloon 638 andnosecone 638, e.g., which may otherwise occur if they are formed fromsimilar materials and/or exposed to elevated temperatures.

As best seen in FIG. 18A, the apparatus 610 also includes a helicalmember or coil 670 coupled between the outer and inner members 620, 630within the balloon interior 656. The helical member 670 may be movablefrom a relatively low profile, such as that shown in FIG. 18A, to anexpanded helical shape, as shown in FIG. 18C and described furtherbelow. The helical member 670 may be a wire, tube, or other filamentincluding a first end 672 coupled to the distal end 624 of the outermember 620 and a second end 674 coupled to the inner member 630. Forexample, similar to other embodiments herein, the helical member 670 maybe formed from a core wire having a tube or sleeve formed or attachedaround the wire (not shown). Alternatively, the helical member 670 maybe formed from a plurality of wires, e.g., braided or otherwise formedtogether into a single filament. Between the first and second ends 672,674, the helical member 670 may wrap helically around the inner member630 one or more times, also similar to other embodiments herein.

As shown, the first end 672 of the helical member 670 may be attached orotherwise secured directly to the distal end 624 of the outer member620, e.g., by one or more of bonding with adhesive, sonic welding,soldering, interference fit (e.g., by wrapping the first end 672 one ormore times around the distal end 624), inserting the first end 672 intoan annular groove, hole, or pocket (not shown) in the distal end 624,fusing, providing a sleeve (not shown) around the distal end 624, andthe like. Alternatively, the first end 672 of the helical member 670 mayextend proximally through or along the outer member 622 or may becoupled to an actuator cable extending along the outer member 622, e.g.,as shown in FIGS. 22A-22D and described further below.

Unlike the previous embodiments, the second end 674 of the helicalmember 670 may be coupled indirectly to the inner member 630, e.g., viaspring element 690, best seen in FIG. 18B. The spring element 690 mayinclude one or more springs or other biasing devices including anintermediate portion fixed to the inner member 630, e.g., by a firstcollar or attachment element 692, a proximal portion 694 coupled to thesecond end 674 of the helical member 670 by a second collar orattachment element 695, and a distal portion 696 extending distally fromthe first attachment element 692. Optionally, a membrane, sheath, orother structure (not shown) may be provided around at least a portion ofthe spring element 690, for example, over the proximal and/or distalportions 694, 696, which may protect the balloon 650 or other featuresof the apparatus 610, e.g., from being captured within windings of thespring element 690.

As best seen in FIG. 18B, the first collar 692 may be attached orotherwise fixed relative to the inner member 630, e.g., by bonding withadhesive, fusing, interference fit, one or more connectors (not shown),and the like. The distal end 697 of the spring element 690 and thesecond collar 695 may float freely around the inner member 630, e.g., toprovide desired bias and/or compliance to the apparatus 610, asexplained further below. Alternatively, the distal end 697 of the springelement 690 may be attached or otherwise fixed to the spring stop 655 orto the distal end 654 of the balloon 650, if desired.

The first collar 692 may be located generally at a midpoint on thespring element 690 or may be located closer to one end than the other.For example, as shown in FIG. 18B, the first collar 692 may be attachedto the spring element 690 closer to the second collar 695 than to thedistal end 697. Thus, in this embodiment, the distal portion 696 of thespring element 690 includes more windings than the proximal portion 694,although it will be appreciated that fewer or more windings may beprovided in either the proximal or distal portions 694, 696, e.g., toprovide predetermined spring properties, as desired.

In one embodiment, the spring element 690 may be a single spring havinga substantially uniform spring constant and/or other mechanicalproperties along its length, or the properties may be varied, e.g.,between the proximal portion 694 and the distal portion 696. In analternative embodiment, the proximal and distal portions 694, 696 may beseparate springs independently attached to the first collar 692, eachhaving desired properties for their respective purposes, e.g., biasingand/or providing compliance to the apparatus 610, as described furtherbelow. The spring element 690 may be formed from one or more materials,e.g., metal, such as stainless steel, thermoplastic, thermoset plastics,glass, or composite materials.

As best seen in FIG. 18B, the distal portion 696 of the spring element690 may terminate in a distal end 697 for contacting the spring stop655, e.g., to bias the inner member 630 axially relative to the balloondistal end 654. Optionally, the distal end 697 may include a planar ringdefining a plane substantially perpendicular to the longitudinal axis627, e.g., to provide enhanced apposition against the spring stop 655,if desired. The distal portion 696 of the spring element 690 may have adiameter smaller than the distal end 654 of the balloon 650 and largerthan the inner diameter of the spring stop 655, e.g., such that thedistal portion 696 may move freely within the distal end 654 of theballoon 650 limited by contact between the distal end 697 and the springstop 655, as described further below.

The first collar 692 may be offset proximally from the nosecone 638 by apredetermined distance and/or the distal portion 696 of the springelement 690 may have a predetermined length to provide a desired bias.For example, these distances and/or the spring constant of the distalportion 696 may be such that the spring element 690 biases the nosecone638 against the distal end 654 of the balloon 650, e.g., tosubstantially seal the outlet 658, yet allow the inner member 630 to bedirected distally to move the nosecone 638 away from the balloon 650 toopen the outlet 658, as described further below.

As shown in FIGS. 18A and 18B, the second end 674 of the helical member670 and the proximal end 694 of the spring element 690 are attached tothe second collar 695, e.g., by bonding with adhesive, fusing,interference fit, one or more connectors (not shown), and the like. Thesecond collar 695 may be free to move axially relative to the innermember 630, e.g., without substantial lateral movement, to providecompliance to the helical member 670, as described further below.

Optionally, the apparatus 610 may include one or more markers (notshown) to facilitate positioning and/or advancement of the apparatus 610during use, e.g., on the distal end 634 of the inner member 630, balloon650, and/or helical member 670, similar to other embodiments herein.

Turning to FIGS. 19A-19C, the handle 660 may be coupled to or otherwiseprovided on the proximal end 622 of the outer member 620, e.g., formanipulating the outer member 620 and/or the entire apparatus 610,similar to the previous embodiments. The handle 660 generally includes ahousing 661 attached to the outer member 620, and may include one ormore ports 664 for accessing the lumens of the apparatus 610 and/or oneor more actuators 662 for operating features of the apparatus 610.

For example, the handle 660 may include a first side port 664 a thatcommunicates with the annular first lumen 626 in the outer member 620,and may include a connector, e.g., a Luer lock fitting, for coupling oneor more fluid or vacuum sources to the apparatus 610, e.g., a syringe orother source (not shown) for delivering fluid through the first lumen626 into the interior 656 of the balloon 650 and/or through the outlet658 (depending upon the position of the inner member 630). In addition,the handle 660 may include a second port 664 b that communicates withthe second lumen 636 of the inner member 630. The second port 664 b mayinclude one or more seals, e.g., a hemostatic seal (not shown), that mayaccommodate receiving a guidewire or other instrument (not shown)through the second port 664 b into the second lumen 636 whilemaintaining a substantially fluid-tight seal to prevent substantialfluid flow proximally from the second lumen 636.

In addition, the handle 660 may include a slider, thumb control, pushbutton, or other actuator 662 coupled to the inner member 630 for movingthe inner member 630, e.g., to open and/or close the outlet 658 (seeFIGS. 18A, 18B) and/or expand and collapse the helical member 670, asdescribed further below and/or similar to other embodiments herein.Optionally, the handle 660 may include one or more seals, bushings, andthe like (not shown), between the outer and inner members 620, 630,which may guide the inner member 630 as it moves axially relative to theouter member 630 and handle 660, e.g., also similar to other embodimentsherein.

FIGS. 20A-20C show an alternative embodiment of a handle 660′ that maybe generally similar to the handle 660 shown in FIGS. 19A-19C, e.g.,including a housing 661′ that includes side ports 664′ and a slot 663′within which a push button, thumb control, or other actuator 662′ moves.Unlike the handle 660, the housing 661′ may include a clip or otherreceptacle 668′ for engaging a guidewire or other instrument 699received in the side port 664 b′. For example, as best seen in FIG. 20C,a recess 688 a′ may be provided on the bottom of the housing 661′ withinwhich a pair of opposing flexible members, rubber molding or otherstructures 668 b′, and the like are attached. A guidewire 699 is shownpressed into the recess 668 a′ between and/or under the structures 668b′ to removably capture the guidewire 699 in the recess 668 a′.Alternatively, the clip 668′ may include other opposing elements, e.g.,ridges, cleats, and the like (not shown), mounted or otherwise attachedto the housing 661′. Although the clip 668′ is shown on the bottom ofthe housing 661′, it will be appreciated that the clip 668′ may beprovided on other surfaces or locations of the housing 661′, e.g., at alocation that minimizes interference with holding and/or operating thehandle 660′.

During use, a guidewire 699 or other instrument may be introducedthrough the second port 664 b′, e.g., by insertion into the second port664 b′ or by backloading into the distal end 634 of the inner member 630(not shown), such that a proximal end 699 a of the guidewire 699 extendsproximally from the second port 664 b′. The exposed portion of theguidewire 699 may be looped back and the proximal end 699 a captured inthe clip 668′, e.g., by pressing the proximal end 699 a through thestructures 668 b′ into the recess 668 a′. Friction of the structures 668b′ may releasably retain the proximal end 699 a in the recess 668 a′ Ifdesired to move or otherwise manipulate the proximal end 699 a, theguidewire 699 may be pulled away from the housing 661′ to open thestructures 668 b′ and remove the proximal end 699 a from the clip 668′.Thus, the clip 668′ may be useful for managing long guidewires or otherinstruments, which may otherwise fall off a procedure table or riskleaving a sterile field in which a procedure is being performed.

FIGS. 28A and 28B show another exemplary embodiment of a handle 660′″generally similar to those described above, e.g., including a housing661′″ that includes side ports 664′″ and a push button, thumb control,or other actuator 662′″ that moves within or otherwise relative to aslot or track 663.′″ As shown in FIG. 28A, the housing 661′″ may includemating clam shell halves that may be attached together, e.g., by bondingwith adhesive, sonic welding, fusing, mating connectors, and the likealong a seam therebetween, to define the slot 663′″ and grippingsurfaces for the handle 660.′″

FIG. 28B shows an exemplary configuration of internal components of thehandle 660′″ after the housing 661′″ shown in FIG. 28A has been removedfor clarity. As shown, the handle 660′″ includes stationary componentsthat are coupled to the outer member 620 and/or housing 661,′″ e.g., amanifold 680,′″ a stress relief transition 682,′″ and a proximalhypotube or other tubular body 690 a,′″ and movable components that arecoupled to the inner member 630 and movable axially within the housing661,′″ e.g., a carriage 684′″ and a distal hypotube or other tubularbody 690 b.′″

For example, the manifold 680′″ and transition 682′″ may be attached toor otherwise substantially fixed relative to the housing 661′″ and theproximal end 622 of the outer member 620 may be received in and/orattached to the transition 682′″ and/or manifold 680′″ such that thesecomponents remain substantially stationary relative to the handle 660.′″The manifold 680′″ includes an inner chamber or passage 681′″ thatcommunicates with the first lumen 626 of the outer member 620. A Luerfitting or other connector may be attached to the manifold 680′″ toprovide a first side port 664 a′″ that communicates with the chamber681′″ and, consequently, with the first lumen 626.

The proximal tubular body 690 a′″ may also be substantially fixed orotherwise mounted to the housing 661′″ with a proximal end extendingfrom the housing 661′″ and including a Luer fitting to provide a secondside port 664 b,′″ e.g., for receiving a guidewire or other instrument(not shown), similar to other embodiments herein. The distal end of theproximal tubular body 690 a′″ may be received within the carriage 684′″such that the carriage 684′″ may be slid axially at least partially overthe proximal tubular body 690 a.′″ As shown, the carriage 684′″ mayinclude an o-ring or other seal 686 a,′″ e.g., received within aretainer or seat, to provide a substantially fluid-tight seal betweenthe proximal tubular body 690 a′″ and carriage 684′″ while the carriage684′″ moves.

The carriage 684′″ may be supported within the housing 661′″ such thatthe carriage 684′″ is free to move axially therein between proximal anddistal positions with minimal lateral movement. The actuator 662′″ maybe attached or otherwise coupled to the carriage 684′″ such that theactuator 662′″ extends through the slot 663′″ in the housing 661,′″similar to the previous embodiments. The distal tubular body 690 b′″ mayinclude a proximal end received in and/or otherwise fixed relative tothe carriage 684′″ and a distal end that extends through the manifold680′″ and/or transition 682′″ to accommodate attaching the distaltubular body 690 b′″ to the inner member 630. The manifold 680′″ mayalso include an o-ring or other seal 686 b,′″ e.g., received within aretainer or seat, to provide a substantially fluid-tight seal betweenthe distal tubular body 690 b′″ and the manifold 680′″ whileaccommodating axial movement of the distal tubular body 690 b.′″ Thus,fluid introduced into the chamber 681′″ of the manifold 680′″ via thefirst side port 664 a′″ may pass into the lumen 626 of the outer member620 without substantial leakage.

Similar to previous embodiments, the actuator 662′″ may be directedaxially between two or more positions, thereby causing the carriage684′″ to slide axially within the housing 661′″ and, consequently,direct the distal tubular body 690 b′″ and inner member 630 to moveaxially relative to the outer member 620 and handle 660.′″

Returning to FIGS. 19A-19C, the housing 661 may include an elongate slot663 and the actuator 662 may be slidable generally axially within theslot 663 to direct the apparatus 610 between one or more modes ofoperation. For example, the slot 663 may include three distinct axialregions 663 a, 663 b, 663 c connected by diagonal regions 663 d, 663 e,which may correspond to three different modes of operation for theapparatus 610. With the actuator 662 in the second region 663 b, asshown in FIG. 19A, the inner member 630 may be positioned axially suchthat the nosecone 638 contacts the distal end 654 of the balloon 650 tosubstantially seal the outlet 658, as shown in FIG. 18A.

If balloon inflation is desired during injection, the distal balloonsection 654 may be sized to offer resistance to flow. This resistance toflow may cause at least partial inflation of the balloon 650 while alsodelivering fluid from the outlet 658. Alternatively, the balloon section654 may be made large enough not to offer significant resistance toflow, in which case fluid may be delivered from the outlet 658 while theballoon 650 remains substantially collapsed.

When the actuator 662 is directed distally into the first region 663 a,as shown in FIG. 19B, the inner member 630 is advanced distally todirect the nosecone 638 away from the distal end 654 of the balloon 650and open the outlet 658, e.g., as shown in FIG. 18B. When the actuator662 is directed proximally into the third region 663 c, the inner member630 may be retracted proximally to expand the helical member 670. Ifdesired, the third region 663 c may have sufficient length to allow theactuator 662 to be directed along the length of the third region 663 c,e.g., to vary the size of the helical member 670 in the expanded helicalshape. For example, the actuator 662 may be placed in any intermediateposition along the third region 663 c with the helical member 670growing to a progressively larger diameter as the actuator 662 isdirected proximally within the third region 663 c. Thus, by modulatingthe position of the actuator 662 within the third region 663, a user maycontrol the diameter of the helical member 670 to approximate the sizeof the anatomy encountered.

Optionally, the slot 663 may include one or more pockets or detents (notshown) that may capture a feature on the actuator 662, e.g., toreleasably secure the actuator 662 in one or more of the positions,e.g., similar to other embodiments herein. In addition or alternatively,the housing 661 may include one or more visual indicators (not shown),e.g., for identifying the position of the inner member 630 and/or modeof the apparatus 610 when the actuator 662 is received in a particularregion or pocket, also similar to other embodiments herein.

The apparatus 610 may be biased to one of the three modes, e.g., suchthat the actuator 662 is biased to move into one of the regions 663a-663 c yet may be selectively directed into one of the other regions663 a-663 c to direct the apparatus 610 to one of the other modes. Forexample, as described above, spring element 690 may include distalportion 696, which may bias the inner member 630 proximally to engagethe nosecone 638 with the distal end 654 of the balloon 650 tosubstantially seal and/or enhance sealing the outlet 658, as shown inFIG. 18B. The length of the distal portion 696 and relative locations ofthe first collar 692 and spring stop 655 may be set such that the distalportion 696 is under slight compression when the nosecone 638 is engagedwith the distal end 654 of the balloon 650, which may ensure that theoutlet 658 is maintained substantially sealed. Consequently, theactuator 662 may be biased towards the second region 663 b, as shown inFIG. 19B.

In addition, the proximal portion 694 of the spring element 690 mayprovide compliance to the helical member 670, e.g., as it is directedbetween the first and second modes. For example, with the actuator 662in the second region 663 b, the proximal portion 694 of the springelement 690 may maintain sufficient tension on the helical member 670 toconstrain the helical member 670 closely around the inner member 630. Ifthe distal end 674 of the helical member 670 were attached directly tothe inner member 630, sufficient slack would need to be provided toaccommodate advancement of the inner member 630 to open the outlet 658,which may increase the profile of the helical member 670 and,consequently, the overall apparatus 610.

When the actuator 662 is advanced to the first region 663 a, the firstcollar 692 moves distally, and the proximal portion 694 of the springelement 690 may absorb most or substantially all of the resultingdisplacement. For example, the proximal portion 694 may have sufficientelasticity to extend axially rather than the helical member 670 beingsubjected to substantial axial tension, which could apply a proximalforce that may interfere with opening the outlet 658 (i.e., the helicalmember 670 may otherwise operate as a spring against the desired distalmovement of the inner member 630). The proximal portion 692 of thespring element 690 may also reduce distal tension that may otherwisepull the distal end 674 of the helical member 670 distally, potentiallystretching or plastically deforming the helical member 670 when theoutlet 658 is opened.

With additional reference to FIGS. 21A-21D, during use, the apparatus610 may be provided to a user as shown in FIG. 21A, i.e., with theballoon 650 and helical member 670 collapsed, and the valve provided bythe nosecone 638 sealed, i.e., with the actuator 662 in the secondregion 663 b of the slot 663. For example, as explained above, thenosecone 638 may be biased to seal the outlet 658 in the distal end 654of the balloon 650, thereby biasing the actuator 662 towards the secondregion 663 b.

The distal end of the apparatus 610 may be introduced into a patient'sbody, e.g., into a body lumen (not shown), similar to the previousembodiments, with the outlet 658 substantially sealed. At a desiredlocation, the actuator 662 may be advanced into the first region 663 a,as shown in FIG. 19B, thereby directing the apparatus 610 to theinfusion mode, i.e., moving the nosecone 638 away from the distal end654 of the balloon 650 to open the outlet 658 and compressing the distalportion 696 of the spring element 690, e.g., as shown in FIG. 18B(although without expanding the balloon 650). Thus, fluid introducedinto the first port 664 a and through the first lumen 626 of the outermember 620 may pass through the balloon interior 656 and out the outlet658, e.g., into the body lumen beyond the nosecone 638, withoutsubstantially expanding the balloon 650, similar to the previousembodiments. Alternatively, as described above, the outlet 658 mayprovided sufficient resistance to fluid flow therethrough that theballoon 650 is at least partially expanded as fluid is delivered throughthe outlet 658. In the infusion mode, contrast, diagnostic ortherapeutic fluids, and the like may be introduced into the body lumen,while the apparatus 610 is manipulated or maintained substantiallystationary, similar to the previous embodiments.

After sufficient fluid has been delivered and/or it is otherwise desiredto seal the outlet 658, the actuator 662 may be retracted into thesecond region 663 b, thereby directing the inner member 630 proximallyuntil the nosecone 638 engages the distal end 654 of the balloon 650,substantially sealing the outlet 658, as shown in FIGS. 18A and 21B. Thespring element 690 may have a spring constant that provides sufficientbias to ensure that the outlet 658 is substantially sealed by thenosecone 638. Alternatively, the spring element 690 may providesufficient bias such that, when the actuator 662 is released, the energystored in the distal portion 696 of the spring element 690 mayautomatically direct the inner member 630 proximally until the nosecone638 engages the distal end 654 of the balloon 650, substantially sealingthe outlet 658. Consequently, the actuator 662 may be directedautomatically back into the second region 663 b of the slot 663, and thespring element 690 may provide a positive valve closure of the outlet658. This may be useful because the force to close the outlet 658 isprovided by the spring element 690 at the distal end of the apparatus610 and does not rely on forces being transmitted over the length of theapparatus 610, which may otherwise be subject to axial compliance withinthe inner and outer members 630, 620 and therefore less reliable.

As shown in FIG. 21B, in the second mode, any fluid introduced throughthe first lumen 626 enters the balloon interior 656 and expands theballoon 650, similar to the previous embodiments. For example, in thismode, the balloon 650 may be expanded to an elongate substantiallycylindrical shape, e.g., having a substantially uniform diameter mainportion between tapered end portions. The balloon 650 may be used todilate or otherwise apply substantial pressure to a wall of a bodylumen, e.g., for dilating a stenosis, obstruction, or other lesion,similar to the method shown in FIGS. 9E-9G and described elsewhereherein. Alternatively, the balloon 650 may be formed from elastic and/orsubstantially compliant material such that the balloon 650 may beexpanded within a body lumen and directed axially to remove materialwithin the body lumen, similar to other embodiments herein.

In addition, as shown in FIG. 19C, the actuator 662 may be retractedinto the third region 663 c to direct the apparatus 610 to the thirdmode shown in FIGS. 18C and 21D, e.g., for removing thrombus or otherundesired material within a body lumen, similar to the other embodimentsherein. For example, with the balloon 650 collapsed, the actuator 662may be retracted to direct the inner member 630 proximally, therebyaxially compressing the helical member 670 and directing the distal end674 of the helical member 670 proximally towards the proximal end 672.Similar to other embodiments herein, this causes the helical member 670to expand radially outwardly as it is compressed axially, therebycausing the balloon 650 also to compress axially and expand radiallyinto an expanded helical shape around the helical member 670, as shownin FIGS. 18C and 21D.

The length of the third region 663 c of the slot 663 may limit proximalmovement of the inner member 630 in a predetermined manner whencompressing and expanding the balloon 650 and helical member 670, e.g.,to prevent over-compression of the balloon 650 and/or helical member670. For example, as described above, the actuator 662 may be placed inany intermediate position along the length of the third region 663 c tovary the diameter of the helical member 670 in the expanded helicalshape. By modulating the position of the actuator 662 along the thirdregion 663 c, the user may control the diameter of the helical member670 to correspond to the patient's vasculature, e.g., to providesufficient friction and/or engagement with the wall of a body lumenbeing treated to remove sufficient material from the wall.

If the balloon 650 has been previously inflated, a source of vacuum,e.g., a syringe or vacuum line (not shown), may be coupled to the sideport 664 a to evacuate fluid from the interior 656 to collapse theballoon 650 to the contracted condition around the helical member 670before directing the actuator 662 into the third region 663 c.Alternatively, if the balloon 650 has not been previously inflated,e.g., if thrombus is to be removed before dilating a body lumen, it maynot be necessary to collapse the balloon 650 further using vacuum sincethe balloon 650 may already be sufficiently collapsed or otherwiseremain in the contracted condition.

Alternatively, as shown in FIGS. 21C and 21D, the actuator 662 may bedirected from the second region 663 b to the third region 663 c whilethe balloon 650 remains inflated. For example, as shown in FIG. 21B, theballoon 650 may be inflated (if not already inflated) while the helicalmember 670 remains wound closely around the inner member 630. Turning toFIG. 21C, the inner member 630 may be directed proximally relative tothe outer member 620, e.g., by directing the actuator 662 proximallyinto the third region 663 c, as described above. This may cause theballoon 650 to buckle but remain generally cylindrical as it iscompressed axially, e.g., due to being partially constrained within abody lumen and/or fluid remaining within the interior 656 of the balloon650.

Optionally, the apparatus 610 may include one or more relief valves orother features (not shown), e.g., on the handle 660 or other location onthe proximal end 622 of the outer member 620, that communicate with thefirst lumen 626 to prevent overexpansion of the balloon 650 as it isaxially compressed. For example, a relief valve may bleed excess fluidfrom the interior 656 of the balloon 650 as the inner member 630 isdirected proximally, thereby automatically reducing the volume of fluidwithin the interior 656 of the balloon 650 and/or the first lumen 626.Alternatively, a manual valve or other feature (not shown) may beprovided on the handle 660 that may be opened by the user before or asthe inner member 630 is directed proximally or that is activated whenthe actuator 662 is directed along the slot 663 to a predeterminedposition within or adjacent the third region 663 c.

As shown in FIG. 21C, the helical member 670 may expand radiallyoutwardly within the expanded balloon 650 as the inner member 630 isdirected proximally to adopt the expanded helical shape. Movement of thehelical member 670 may be relatively unimpeded by the balloon 650, whichmay allow the helical member 670 to expand more uniformly than if thehelical member 670 were expanded within a collapsed balloon 650. Inaddition, because the balloon 650 is already inflated, expansion of thehelical member 670 in this manner may reduce the risk of creating tightfolds or other stress on the balloon 650 as the helical member 670expands, which may otherwise damage the balloon 650.

Turning to FIG. 21D, once the helical member 670 is sufficientlyexpanded, the balloon 650 may be deflated, allowing the balloon 650 tocollapse around and substantially adopt the shape of the expandedhelical member 670. Thus, the balloon 650 may provide a substantiallyimpervious layer around the helical member 670, which may preventmaterial being removed from being captured within or around the helicalmember 670. The collapsed balloon 650 draped around the expanded helicalmember 670 may also provide mechanical reinforcement to the helicalmember 670, e.g., to provide a more robust helical structure forremoving thrombus or other material within the body lumen.

After sufficient thrombus or other material is removed, the balloon 650may be partially or fully inflated again, and the actuator 662 and innermember 630 may be advanced distally to direct the helical member 670back towards the low profile around the inner member 630. Once theactuator 662 and inner member 630 are advanced to the second position,the balloon 650 may be deflated, e.g., by coupling a source of vacuum tothe first port 664 a, and/or the actuator 662 and inner member 630 maybe advanced to the distal position to open the valve. Alternatively, theinner member 630 may be advanced distally with the balloon 650 remainingcollapsed to direct the helical member 670 towards the low profile,similar to the previous embodiments. Once collapsed, the apparatus 610may be directed to another location within the patient's body, e.g., foradditional fluid infusion, dilation, and/or thrombus removal, or removedentirely from the patient's body.

Turning to FIGS. 22A-22D, another exemplary embodiment of an apparatus610″ is shown for treating a body lumen that includes an outer member620,″ an inner member 630,″ a balloon 650,″ a nosecone 638,″ a springelement 690,″ and a handle 660,″ which are generally constructed andoperated similar to the apparatus 610. Although the apparatus 610″includes a helical member 670′ with a distal end 674″ coupled to theinner member 630,″ e.g., via the spring element 690,″ unlike theapparatus 610, a proximal end 672″ of the helical member 670″ is notcoupled to the outer member 620.″ Instead, the proximal end 672″ of thehelical member 670″ may be coupled to an actuator cable, wire, or otherelongate member 673″ that extends proximally through the outer member620″ and is coupled to a first actuator 662 a″ on the handle 660.″

Thus, axial movement of the inner member 630″ relative to the outermember 620″ may be substantially independent of expansion and/orcollapse of the helical member 670.″ For example, a second actuator 662b″ on the handle 660″ may be directed to move the inner member 620″ andnosecone 638″ to open and/or close the outlet 658,″ similar to theembodiments described above. However, the distal end 674″ of the helicalmember 670″ may be substantially decoupled from such movement, e.g., bythe spring element 690,″ similar to the previous embodiment. Instead,the first actuator 662 a″ may be directed axially, as shown in FIGS. 22Band 22C, to direct the actuator member 673″ axially. This action maydirect the proximal end 672″ of the helical member 670″ distally towardsthe distal end 674″ to expand the helical member 670,″ or proximallyaway from the distal end 674″ to collapse the helical member 670.″

During use, the apparatus 610″ may be provided to a user as shown inFIG. 22A, i.e., with the balloon 650″ and helical member 670″ collapsed,and the nosecone 638″ substantially sealing the outlet 658.″ Forexample, as explained above, the inner member 630″ and, consequently,the nosecone 638″ may be biased by the spring element 690″ tosubstantially seal the outlet 658″ in the distal end 654″ of the balloon650, and the second actuator 662 b″ in a proximal position. If it isdesired to infuse fluid through the first lumen 626″ of the outer member620,″ the second actuator 662 b″ may be directed to a distal position,thereby advancing the inner member 630″ and nosecone 638″ away from thedistal end 654″ of the balloon 650″ to open the outlet 658,″ e.g., asdescribed above. When the second actuator 662 b″ is retracted, thenosecone 638″ may substantially seal the outlet 658″ with the springelement 690″ providing sufficient bias to enhance the seal.Alternatively, the spring element 690″ may provide sufficient bias suchthat, when the second actuator 662 b″ is released, the nosecone 638″ mayautomatically seal the outlet 658″ and the second actuator 662 b″ mayautomatically retract to its proximal position, similar to otherembodiments herein.

As shown in FIG. 21B, with the second actuator 662 b″ in the proximalposition, any fluid subsequently introduced through the first lumen 626″enters the balloon interior 656″ and expands the balloon 650,″ similarto the previous embodiments. For example, in this mode, the balloon 650″may be used to dilate or otherwise apply substantial pressure to a wallof a body lumen, e.g., for dilating a stenosis, lesion, or otherobstruction, similar to the methods described elsewhere herein.

If desired, with the balloon 650″ expanded, the actuator 662 a″ may beadvanced to its distal position to expand the helical member 670″radially outwardly within the balloon 650″, as shown in FIG. 22C. As thehelical member 670″ is expanded, the balloon 650″ may remain fullyexpanded without substantially shortening, which may reduce theformation of folds in the balloon 650″ as may occur in the previousembodiments. Thus, the helical member 670″ may expand freely to adesired helical shape without substantial interference from the balloon650.″ As shown in FIG. 22D, once the helical member 670″ is sufficientlyexpanded, the balloon 650″ may be deflated, e.g., by opening the valveand/or aspirating fluid from the balloon 650,″ allowing the balloon 650″to collapse around and substantially adopt the shape of the expandedhelical member 670,″ as described above.

After sufficient thrombus or other material is removed, the balloon 650″may be partially or fully inflated again, and the actuator 662 a″ may beretracted proximally to direct the helical member 670″ back towards thelow profile around the inner member 630.″ Once the actuator 662 a″ isdirected to its proximal position, the balloon 650″ may be deflated andthe apparatus 610″ may be directed to another location or removed fromthe patient's body.

Turning to FIGS. 29, 30A, and 30B, still another embodiment of anapparatus 710 is shown for treating a body lumen that is generallysimilar to the previously embodiments, e.g., generally similar toapparatus 610 shown in FIGS. 18A-19C without the helical member 670.

For example, the apparatus 710 includes an outer tubular member 720, aninner member 730, and an expandable balloon 750 carried by the innerand/or outer members 720, 730, generally similar to the previousembodiments. In addition, the apparatus 710 includes a handle or hub 760coupled to or otherwise provided on a proximal end 722 of the outermember 720, e.g., for manipulating the outer member 720 and/or theentire apparatus 710, also generally similar to the previousembodiments. Also similar to previous embodiments, the apparatus 710 mayinclude an actuator 762 on the handle 760 for operating the apparatus710 in multiple modes, e.g., a first mode for dilating an obstructionwithin a body lumen (shown in FIG. 30A), and a second mode for infusingfluid into a body lumen (shown in FIG. 30B, although with the balloon750 collapsed).

As shown, the outer member 720 includes a proximal end 722, a distal end724 sized for introduction into a body lumen, and a first lumen 726extending along a central longitudinal axis 727 therebetween, which maybe constructed similar to the previous embodiments. The inner member 730also includes a proximal end (not shown), a distal end 734, and,optionally, a second lumen 736, e.g., sized to slidably receive aguidewire or other instrument (not shown) therethrough. The inner member730 is sized to be slidably received within the first lumen 726 of theouter member 720, e.g., such that an annular space is defined betweenthe outer and inner members 720, 730 for passing one or more fluidstherethrough, also similar to the previous embodiments. One or moresealing members, e.g., a nosecone 738, may be provided on the distal end734 of the inner member 730 to provide a valve, also similar to theprevious embodiments.

As best seen in FIG. 30A, the balloon 750 includes a proximal end 752coupled to the outer member distal end 724, a distal end 754 defining anoutlet 758, and an interior 756 communicating with the first lumen 726and the outlet 758. The distal end 734 of the inner member 730 mayextend through the distal end 754 of the balloon 750, e.g., such thatthe outlet 758 defines an annular passage between the distal end 754 ofthe balloon 750 and the distal end 734 of the inner member 730 whenopen. The distal end 754 of the balloon 750 includes a spring stop,e.g., a collar or sleeve 755, attached or otherwise secured within thedistal end 754, e.g., by bonding with adhesive, interference fit, sonicwelding, fusing, and the like. The spring stop 755 may be spacedproximally from the outlet 758, e.g., such that the spring stop 755 doesnot interfere substantially with fluid flowing through the outlet 758when the nosecone 738 is directed away from the outlet 758, similar tothe previous embodiments.

A spring element 790 may be coupled to the inner member 730, e.g., by acollar or other attachment element 792, such that the spring element 790may be compressed between the collar 792 and the spring stop 755, e.g.,to bias the nosecone 738 to substantially seal the outlet 758, similarto the previous embodiments. For example, a proximal or first end 790 aof the spring element 790 may be attached or otherwise coupled to thecollar 792 and a distal or second end 790 b of the spring element 790may be coupled to or merely in contact with the spring stop 755.

The collar 792 may be attached or otherwise fixed relative to the innermember 730, e.g., by bonding with adhesive, fusing, interference fit,one or more connectors (not shown), and the like. The distal end 790 bof the spring element 790 may float freely around the inner member 730,e.g., to provide desired bias to the apparatus 710, similar to theprevious embodiments. Optionally, the distal end 790 b may include aplanar ring defining a plane substantially perpendicular to thelongitudinal axis 727, e.g., to provide enhanced apposition against thespring stop 755, if desired. The spring element 790 may have a diametersmaller than the distal end 754 of the balloon 750 and larger than theinner diameter of the spring stop 755, e.g., such that the springelement 790 may move freely within the distal end 754 of the balloon 750limited by contact between the distal end 790 b and the spring stop 755.Alternatively, the distal end 790 b of the spring element 790 may beattached or otherwise fixed to the spring stop 755 or to the distal end754 of the balloon 750, if desired.

The collar 792 may be located on the inner member 730 such that thecollar 792 does not interfere substantially with fluid flow through thedistal end 754 and the outlet 758 when the outlet 758 is open, e.g., asshown in FIG. 30B. For example, the collar 792 may be offset proximallyfrom the nosecone 738 by a predetermined distance and/or the springelement 790 may have a predetermined length to provide the desired biaswithout interfering with fluid flow. Similar to the previousembodiments, these lengths and/or the spring constant of the springelement 790 biases the nosecone 738 against the distal end 754 of theballoon 750, e.g., to substantially seal the outlet 758, yet allow theinner member 730 to be directed distally to move the nosecone 738 awayfrom the balloon 750 to open the outlet 758.

Optionally, a membrane, sheath, or other structure (not shown) may beprovided around at least a portion of the spring element 790, e.g., toprotect the balloon 750 or other features of the apparatus 710, e.g.,from being captured within windings of the spring element 790, similarto the previous embodiments. In addition or alternatively, the apparatus710 may include one or more markers (not shown) to facilitatepositioning and/or advancement of the apparatus 710 during use, e.g., onthe distal end 734 of the inner member 730 and/or the balloon 750,similar to other embodiments herein.

Unlike the previous embodiments, the distal end 754 of the balloon 750includes a distal extension or tip 780 that is shaped and/or otherwiseconfigured to facilitate opening and/or closing of the outlet 758. Forexample, as best seen in FIG. 30B, the distal end 754 of the balloon 750may terminate in a distal tip 780 that is flared outwardly away from theballoon 750, i.e., in the distal direction. The distal tip 780 may beintegrally formed from the distal end 754 of the balloon 750, e.g.,extruded or blown from the same material as the entire balloon 750, ormay be formed separately and attached to the distal end 754, e.g., bybonding with adhesive, sonic welding, fusing, and the like.

Optionally, the distal end 754 and/or distal tip 780 of the balloon 750may include a coating or other liner 757, e.g., adjacent the spring stop755. For example, the liner 757 may include a lubricious and/or lowsurface energy material, e.g., PTFE, applied to the interior portion ofthe distal tip 780 and/or distal end 754 of the balloon 750 that maycontact the nosecone 738, e.g., to reduce friction and/or adhesionbetween the balloon 750 and the nosecone 738, similar to the previousembodiments.

In an exemplary embodiment, best seen in FIG. 30B, the distal tip 780may flare outwardly in a similar shape as the nosecone 738, e.g., toenhance receiving the nosecone 738 within the distal tip 780 and/ormaximize surface contact therebetween, to substantially seal the outlet758 when closed. In addition or alternatively, the distal tip 780 mayincrease the clearance of the outlet 758 around the nosecone 738 whenopened, thereby increasing the open area of the outlet 758. The distaltip 780 may be biased to the outward flared shape and/or may havesufficient structural integrity to substantially maintain the outwardflared shape when the nosecone 738 is directed away from the tip 780 toopen the outlet 758.

Alternatively, as shown in FIGS. 31A and 31B, the distal tip 780′ may bebiased to a substantially constant diameter, e.g., similar to the distalend 754,′ but may expandable and/or relatively flexible compared to thedistal end 754′ of the balloon 750.′ For example, the distal tip 780′may be sufficiently flexible and/or resilient to expand when thenosecone 738′ is received within the outlet 758.′ To facilitate suchexpansion, the distal tip 780′ may have a wall thickness that issubstantially less than the adjacent distal end 754′ but sufficientlythick to resist tearing or other damage to the distal tip 780.′

Thus, as shown in FIG. 31A, when the nosecone 738′ is seated within thetip 780,′ the distal tip 780′ may resiliently expand to providesubstantial surface contact between the nosecone 738′ and the distal tip780,′ which may enhance the resulting seal. The flexibility of thedistal tip 780′ may also resist indenting or otherwise pressing into thenosecone 738,′ which may facilitate subsequent separation. When thenosecone 738′ is directed away from the distal tip 780′ to open theoutlet 758,′ the distal tip 780′ may resiliently return towards itsoriginal diameter, as shown in FIG. 31B to define the outlet 758.′ Whenthe nosecone 738′ is again seated into the distal tip 780,′ the distaltip 780′ may resist buckling and instead expand freely to enhancesealing without substantial leakage around the distal tip 780.′

Returning to FIG. 29, similar to the previous embodiments, the handle760 may be coupled to or otherwise provided on the proximal end 722 ofthe outer member 720, e.g., for manipulating the outer member 720 and/orthe entire apparatus 710. The handle 760 generally includes a housing761 attached to the outer member 720, and may include one or more ports764 for accessing the lumens of the apparatus 710 and/or one or moreactuators 762 for directing the apparatus 710 between the infusion andexpansion modes.

For example, the handle 760 may include a first side port 764 a thatcommunicates with the annular first lumen 726 in the outer member 720,and may include a connector, e.g., a Luer lock fitting, for coupling oneor more fluid or vacuum sources to the apparatus 710, e.g., a syringe orother source (not shown) for delivering fluid through the first lumen726 into the interior 756 of the balloon 750 and/or through the outlet758 (depending upon the position of the inner member 730 and nosecone738). In addition, the handle 760 may include a second port 764 b thatcommunicates with the second lumen 736 of the inner member 730. Thesecond port 764 b may include a connector, e.g., a Luer lock fittingand/or one or more seals, e.g., a hemostatic seal (not shown), that mayaccommodate receiving a guidewire or other instrument (not shown)through the second port 764 b into the second lumen 736 whilemaintaining a substantially fluid-tight seal.

In addition, the handle 760 may include a slider, thumb control, pushbutton, or other actuator 762 coupled to the inner member 730 for movingthe inner member 730, e.g., to open and/or close the outlet 758 (seeFIGS. 30A, 30B), similar to other embodiments herein. Optionally, thehandle 760 may include one or more seals, bushings, and the like (notshown), between the outer and inner members 720, 730, which may guidethe inner member 730 as it moves axially relative to the outer member730 and handle 760, e.g., also similar to other embodiments herein.

The actuator 762 may be slidable within the slot 763 between a first orproximal position, shown in FIG. 29 for sealing the outlet 758 and asecond or distal position (not shown) for opening the outlet 758, asshown in FIG. 30B.

Turning to FIG. 32, another embodiment of an apparatus 710″ is shownthat is generally similar to the apparatus 710 of FIG. 29 (with likefeatures having the same reference numbers but including a″ thereafter).For example, the apparatus 710″ includes an outer member 720,″ an innermember 730,″ a balloon 750,″ a handle 760″ with actuator 762,″ and aspring element 790″ coupled between a collar 792″ and a spring stop755,″ similar to the previous embodiments. Optionally, the distal end754″ of the balloon 750″ may include a distal tip 780″ shaped and/orotherwise configured to facilitate opening and/or closing of the outlet758,″ similar to the previous embodiments.

Unlike the previous embodiments, the nosecone 738″ includes a beveledtip 739″ (which may be provided on any of the embodiments describedherein) that may be substantially flexible, semi-rigid or substantiallyrigid to facilitate advancement and/or other manipulation of theapparatus 710″ within a body lumen (not shown). For example, the beveledtip 739″ may facilitate crossing obstructions or other features within abody lumen. When an obstruction is encountered by the beveled tip 739,″the apparatus 710″ may be rotated about its longitudinal axis 727″and/or advanced distally, allowing the beveled tip 739″ to climb overand/or around the obstruction and allow further advancement of theapparatus 710.″

Turning to FIGS. 33A and 33B, another alternative distal tip 739′″ isshown that may be provided on apparatus 710′″ (which may be any of theembodiments described elsewhere herein). Generally, the apparatus 710′″includes an outer member 720,′″ an inner member 730,′″ a balloon 750,′″a handle 760′″ with actuator 762,′″ and a spring element 790′″ coupledbetween a collar 792′″ and a spring stop 755,′″ similar to the previousembodiments. Optionally, the distal end 754′″ of the balloon 750′″ mayinclude a distal tip 780′″ shaped and/or otherwise configured tofacilitate opening and/or closing of the outlet 758,′″ similar to theprevious embodiments.

Unlike the previous embodiments, the nosecone 738′″ includes an extended“J” shaped or otherwise curved distal tip 739′″ (which may be providedon any of the embodiments described herein) extending distally from thenosecone 738.′″ The distal tip 739′″ may have a length beyond thenosecone 738,′″ e.g., between about five and forty millimeters (5-40mm). The distal tip 739′″ may be biased to a curved shape, e.g., asshown in FIG. 33B, yet may be substantially flexible such that, when aguidewire 699 or other instrument is inserted through the inner member730,′″ the distal tip 739′″ may be at least partially straightened, asshown in FIG. 33A. The distal tip 739′″ may be useful for tracking theapparatus 710′″ through tortuous vessels or other body lumens (notshown).

For example, during use, the apparatus 710′″ may be advanced over aguidewire or other rail 699, which may substantially straighten thedistal tip 739′″ as shown in FIG. 33A. Because of the flexibility of thedistal tip 739,′″ the apparatus 710′″ may be easily advanced without thedistal tip 739′″ bending the guidewire 699 or otherwise interferingsubstantially with advancement. However, when a tight or angulatedbranch lumen is encountered through which the apparatus 710′″ is to bedirected from a main lumen, the guidewire 699 may be at least partiallywithdrawn, i.e., at least from the distal tip 739′″ such that the distaltip 739′″ resiliently returns towards its “J” or curved shape. Theapparatus 710′″ may then be rotated and/or manipulated axially to insertthe distal tip 739′″ into the target branch lumen and then advanced todirect the distal tip 739′″ sufficiently into the branch lumen. Theguidewire 699 may then be advanced through the distal tip 739′″ and intothe branch lumen to guide the apparatus 710′″ further into the patient'sbody.

Turning to FIGS. 34A-34C, alternative embodiments of a handle are shownthat may be provided on any of the apparatus herein, e.g., the apparatus710, 710,′ 710,″ or 710.′″ For example, FIG. 34A shows a handle 860 thatincludes a housing 861 attached to an outer member 820 (which may any ofthe embodiments herein), and may include one or more ports 864 foraccessing the lumens of the apparatus and/or one or more actuators 862for directing the apparatus between its different modes of operation.

For example, the handle 860 may include a first side port 864 a thatcommunicates with an annular first lumen (not shown) in the outer member820, and may include a connector, e.g., a Luer lock fitting, forcoupling one or more fluid or vacuum sources to the handle 820, similarto the previous embodiments. In addition, the handle 860 may include asecond port 864 b that communicates with a second lumen of an innermember (not shown), which may include a connector, e.g., a Luer lockfitting and/or one or more seals, e.g., a hemostatic seal (not shown),that may accommodate receiving a guidewire or other instrument (also notshown) through the second port 864 b while maintaining a substantiallyfluid-tight seal.

In addition, the handle 860 may include a slider, thumb control, pushbutton, or other actuator 862 coupled to the inner member (not shown)for moving the inner member, e.g., to open and/or close an outlet of aballoon (also not shown), similar to other embodiments herein. As shown,the housing 861 includes a slot 863 including a first or proximal regionthat receives the actuator 762 to seal the outlet and a second or distalregion that receives the actuator 762 to open the outlet, similar to theprevious embodiments.

Unlike the previous embodiments, the handle 860 may include a relativelylong housing 861, e.g., having a length as long as or longer than atypical user's hand. Thus, such an embodiment may facilitate grippingand/or otherwise manipulating the handle 860 and consequently theapparatus in which the handle 860 is incorporated.

In contrast, FIG. 34B shows another embodiment of a handle 860′ thatincludes a relatively short and/or small handle 861.′ Some proceduresmay be performed in relatively tight fields of operation andconsequently, compactness may be more important than the ergonomicbenefits provided by longer handles, such as handle 860 of FIG. 34A.Thus, the handle 860′ may include a slot 863′ that extends substantiallythe entire length of the handle 860.′ Also unlike handle 860, handle860′ of FIG. 34B includes a first side port 864 a′ that extendsdiagonally from the housing 861′ rather than substantially perpendicularto the housing 861.′

FIG. 34C shows yet another embodiment of a handle 860″ similar to handle860′ except that the first side port 864 a″ is located on the end of alength of flexible tubing 865.″ Such tubing 865″ may provide moreflexibility for the relative position of a source of fluid, e.g., asyringe or other inflation device (not shown) coupled to the first sideport 864 a.″ In addition, the first side port 864 a″ may include aLuer-activated valve rather than a standard Luer fitting, such as thosedisclosed in U.S. Pat. No. 3,192,949, 5,390,898, or 5,775,671, theentire disclosures of which are expressly incorporated by referenceherein. Such valves may facilitate preparation and use of a balloon onan apparatus into which the handle 860″ is incorporated. For example,after preparing a path to the balloon to remove all air, e.g., betweenthe first side port 864 a″ along a first lumen of outer member 820 to aninterior of the balloon (not shown), the syringe or other inflationdevice may be removed from the first side port 864 a″ and refilled oranother device may be attached to the first side port 864 a″ withoutsubstantial risk of reintroducing air into the apparatus. Thus, a usermay not need to have all inflation and/or injection devices attachedconcurrently to the apparatus, but may remove and attach variousdevices, as needed during a procedure.

Turning to FIG. 35, still another embodiment of an apparatus 910 isshown for treating a body lumen generally similar to the previouslyembodiments. As shown, the apparatus 910 includes an outer tubularmember 920, an inner member 930, an expandable balloon 950, and a handle960, which may be constructed generally similar to the previousembodiments.

The outer member 920 includes a proximal end (not shown), a distal end924 sized for introduction into a body lumen, and a first lumen 926extending along a central longitudinal axis 927 therebetween, which maybe constructed similar to the previous embodiments. The inner member 930also includes a proximal end (not shown), a distal end 934, and,optionally, a second lumen 936, e.g., sized to slidably receive aguidewire or other instrument (not shown) therethrough. The inner member930 is sized to be slidably received within the first lumen 926 of theouter member 920, e.g., such that an annular space is defined betweenthe outer and inner members 920, 930 for passing one or more fluidstherethrough, also similar to the previous embodiments. One or moresealing members, e.g., a nosecone 938, may be provided on the distal end934 of the inner member 930 to provide a valve, also similar to theprevious embodiments.

Unlike the previous embodiments, the balloon 950 includes proximal anddistal ends 952, 954 that are both attached or otherwise coupled to theouter member 920. The outer member 920 includes one or more openings 929(one shown) in the distal end 924 such that an interior 956 communicateswith the first lumen 926 via the opening(s) 929. The distal end 934 ofthe inner member 930 may extend through the distal end 924 of the outermember 920, e.g., beyond an outlet 958 in the outer member 920 such thatthe outlet 958 defines an annular passage between the outer and innermembers 920, 930. The inner member 930 may be movable relative to theouter member 920 between a first or proximal position where the nosecone938 may be partially received in or otherwise engage the distal end 924of the outer member 920 to substantially seal the outlet 958 and asecond or distal position where the nosecone 938 is spaced away from theouter member 920 to open the outlet 958, similar to the previousembodiments.

The handle 960 may be attached to or otherwise provided on the proximalend of the outer member 920, e.g., for manipulating the outer member 920and/or the entire apparatus 910. Similar to previous embodiments, thehandle 960 may include an actuator (not shown) for operating theapparatus 910 in multiple modes, e.g., a first mode for dilating anobstruction within a body lumen, and a second mode for infusing fluidinto a body lumen. For example, the actuator may be movable from a firstposition where the nosecone 938 substantially seals the outlet 958 and asecond position where the outlet 958 is open.

With the nosecone 938 sealing the outlet 958, any fluid introduced intothe first lumen 926 enters the interior 956 of the balloon 950, therebyexpanding the balloon 950. Unlike the previous embodiments, because boththe proximal and distal ends of the balloon 950 are attached to theouter member 920, the length of the balloon 950 may remain substantiallyconstant during expansion and/or collapse. With the nosecone 938directed away from the outer member 920 to open the outlet 958, theballoon 950 may remain collapsed and any fluid introduced through thefirst lumen 926 may exit the outlet 958 into a body lumen within whichthe apparatus 910 is introduced.

As shown, the inner member 930 may be integrally incorporated into theapparatus 910, similar to the previous embodiments. Alternatively, theinner member 930 may be decoupled or independent from the othercomponents of the apparatus 910. For example, in one embodiment, theinner member 930 may be introduceable into a patient's bodyindependently from the outer member 920, e.g., over a guidewire orinstead of a guidewire. Once the distal end 934 is positioned at adesired location within the patient's body, the rest of the apparatus910, i.e., the outer member 920 with the balloon 950 collapsed may beadvanced over the inner member 930 to the desired location.

For example, the proximal end of the inner member 930 extending from thepatient's body and may be backloaded through the outlet 958, and theouter member 920 advanced until the proximal end of the inner member 930is received in or extends from the handle 960. The relative length ofthe outer and inner members 920, 930 may be such that the outlet 958 isdisposed adjacent the nosecone 938 when the proximal end of the innermember 930 is received in or extends from the handle 960.

If desired, the handle 960 may include a coupler (not shown) that may beactivated to engage the inner member 930 to a push button, thumbcontrol, or other actuator (not shown) on the handle 960 once the outermember 920 is advanced sufficiently over the inner member 930. Thus,subsequently, the actuator may be activated to direct the inner member930 and nosecone 938 axially relative to the outer member 920 to seal oropen the outlet 958. It will be appreciated that other embodimentsdescribed elsewhere herein may be decoupled in this manner, i.e.,provided with the inner member independent from the outer member and/orother components of the apparatus.

Optionally, an independent inner member 930 may include one or moremarkers or other visual indicators (not shown) that may provideconfirmation to a user that the outer member 920 has been advancedsufficiently to place the outlet 958 adjacent the nosecone 938. Forexample, a marker may be provided on the proximal end of the innermember 930 that may be visible when the proximal end of the inner member930 extends from the handle 960, thereby providing a visual indicationthat the nosecone 938 is sealing or adjacent the outlet 958. In additionor alternatively, the outer member 920 may be advanced until the distalend 924 contacts or engages the nosecone 938, which may provide tactilefeedback that the nosecone 938 may be used to seal or open the outlet958.

With the outer member 920 advanced over the inner member 930, the outlet958 may be opened and fluid delivered into the desired location, e.g.,contrast to facilitate imaging the desired location or one or morediagnostic and/or therapeutic agents. If desired to expand the balloon950, the nosecone 938 may be directed proximally to seal the outlet 958,and fluid delivered to inflate the balloon 950, e.g., to dilate astenosis or other lesion at the desired location, similar to the methodsdescribed above. After treating the desired location, the apparatus 910may be directed to another location or removed from the patient's body.For example, the outer and inner members 920, 930 may be removedtogether or the outer member 920 may be removed first (e.g., afterdecoupling the outer member 920 from the inner member 930 if coupledtogether after advancing the outer member 920 over the inner member930).

Turning to FIGS. 36-37C, yet another embodiment of an apparatus 1010 isshown for treating a body lumen that includes an outer tubular member1020, an inner member 1030, and an expandable balloon 1050 carried bythe inner member 1030, which may be constructed generally similar toother apparatus described above. Also similar to the previousembodiments, the apparatus 1010 may be operable in multiple modes, forexample, a first mode for expanding the balloon 1050, e.g., to removematerial, dilate, or otherwise treat a body lumen, and a second mode fordelivering fluid into a body lumen, similar to other embodimentsdescribed elsewhere herein. Unlike previous embodiments, the apparatus1010 includes an outlet and valve proximal to the balloon 1050 ratherthan distal to the balloon 1050.

Generally, the outer member 1020 includes a proximal end (not shown), adistal end 1024 sized for introduction into a body lumen, and a firstlumen 1026 extending between the proximal end and an outlet 1027 in thedistal end 1024. The inner member 1030 also includes a proximal end (notshown), a distal end 1034, and, optionally, may include a second lumen(not shown) extending between the proximal end and an outlet (also notshown), e.g., in a distal tip 1035, which may be sized to slidablyreceive a guide wire or other instrument (not shown) therethrough. Ahandle (not shown) may be provided on the proximal end of the outermember 1020 including an actuator (also not shown) coupled to the innermember 1020 for directing the inner member 1030 axially relative to theouter member 1020 to direct the apparatus 1010 between the differentmodes, similar to other embodiments herein.

The balloon 1050 includes a distal end 1052 coupled to the inner member1030, e.g., adjacent the distal tip 1035, a proximal end 1052 coupled tothe distal end 1034 of the inner member 1030 proximal to the distal tip1035, and an interior 1056. The balloon 1050 may be formed from elasticmaterial, e.g., to provide a compliant or semi-compliant balloon, orfrom substantially inelastic material, e.g., to provide a non-compliantballoon, similar to other embodiments herein.

As best seen in FIGS. 37A and 37B, a sealing member 1038 is alsoprovided on the distal end 1034 of the inner member 1032 adjacent theproximal end 1052 of the balloon 1050. For example, as shown, thesealing member 1038 may be attached to an outer surface of the innermember 1030 and the proximal end 1052 of the balloon 1050 may beattached to the sealing member 1038. As shown, the proximal end 1052 ofthe balloon 1050 extends at least partially over the sealing member 1038and may be attached to the sealing member 1038, e.g., by bonding withadhesive, sonic welding, fusing, interference fit, an exterior collar(not shown), and the like. Thus, the proximal end 1052 of the balloon1050 may have a substantially fluid-tight seal with the sealing member1038. The distal end 1054 of the balloon 1050 may be attached directlyto the inner member 1030, e.g., using similar materials and/or methods.

The sealing member 1038 may have a size, e.g., outer diameter, that islarger than the inner diameter of the lumen 1026 of the outer member1020, e.g., such that the sealing member 1038 may substantially seal theoutlet 1027 of the outer member 1020, as described further below.Optionally, the sealing member 1038 may have a tapered shape, e.g., atapered proximal end 1038 a to facilitate seating or other engagement bythe sealing member 1038 with the outlet 1027 of the outer member 1020.The sealing member 1038 may be formed from flexible material, e.g.,which may enhance engagement with the distal end 1024 of the outermember 1020 to substantially seal the outlet 1027, similar to otherembodiments herein.

As best seen in FIG. 37C, the sealing member 1038 may include one ormore passages 1039 extending generally longitudinally between theproximal end 1038 a and a distal end 1038 b of the sealing member 1038.The passage(s) 1039 may include an annular passage or may include aplurality of passages formed in the sealing member 1038. For example,the sealing member 1038 may be provided as a length of tubing with oneor more longitudinal grooves formed in an inner wall thereof. When thesealing member 1038 is attached to or otherwise placed around the innermember 1030, the groove(s) may extend along the outer wall of the innermember 1030, thereby together defining the passage(s) 1039.Alternatively, enclosed lumens may be formed within the wall of thetubing to provide the passage(s) 1039.

During assembly, the sealing member 1038 may be placed around the innermember 1030 at the desired location on the distal end 1034 and attachedthereto, e.g., by bonding with adhesive, sonic welding, fusing, and thelike. The proximal end 1052 of the balloon 1050 may then be positionedpartially over the sealing member 1038 and attached thereto. Thus, thepassage(s) 1039 may communicate from the outside of the proximal end1038 a of the sealing member 1038 with the interior 1056 of the balloon1050. The distal end 1054 of the balloon 1050 may be attached to thedistal end 1034 of the inner member 1030. Consequently, the interior1056 of the balloon 1050 may be substantially sealed other than thepassage(s) 1039 through the sealing member 1038.

The outer member 1020 may be positioned around the inner member 1030 andthe handle and actuator coupled to the outer and inner members 1020,1030, similar to other embodiments herein. The apparatus 1010 may beoperated in a first mode for delivering fluid into a body lumen (notshown) into which the apparatus 1010 is introduced and a second mode forinflating the balloon 1050. For example, the inner member 1030 may bemovable between a first or distal position, shown in FIG. 37A, where thesealing member 1038 is spaced apart from the outlet 1027 of the outermember 1020, and a second or proximal position, shown in FIG. 37B, wherethe sealing member 1038 is seated against and/or partially within theoutlet 1027. In the first position, fluid delivered through the lumen1026 of the outer member 1020 may exit the outlet 1027 and enter thebody lumen proximal to the balloon 1050. In the second position, fluiddelivered through the lumen 1026 may enter through the passage(s) 1039in the sealing member 1038 and into the interior 1056 of the balloon1050, thereby inflating the balloon 1050.

During use, the apparatus 1010 may be introduced into a body lumen (notshown), e.g., using similar methods to other embodiments herein. Theapparatus 1010 may be provided with the inner member 1030 in theproximal position such that the sealing member 1038 is seated into theoutlet 1027. This may provide a substantially smooth transition for thedistal end 1024 of the outer member 1020 (in addition to sealing theoutlet 1027), e.g., which may facilitate advancement of the apparatus1010 with minimal risk of damaging the walls of body lumens, e.g., whenthe apparatus 1010 is advanced through tortuous anatomy. Alternatively,the apparatus 1010 may be introduced with the inner member 1030 in thedistal position.

At any time, if it desired to deliver fluid into the body lumen, e.g.,contrast to facilitate fluoroscopy or other external imaging, the innermember 1030 may be directed to the distal or first position to space thesealing member 1038 from the distal end 1024 of the outer member 1020and open the outlet 1027 (FIG. 37A). Fluid may then be delivered throughthe lumen 1026 of the outer member and out the outlet 1027 into the bodylumen. Because the outlet 1027 is spaced away from the sealing member1038, substantially all of the fluid is injected into the body lumen anddoes not pass through the passage(s) 1039 into the balloon 1050.

When it is desired to expand the balloon 1050, the inner member 1030 maybe directed to the proximal or second position to seat the sealingmember 1038 at least partially in the outlet 1027 of the outer member1020 (FIG. 37B). The sealing member 1038 may provide a substantiallyfluid-tight seal with the distal end 1024 of the outer member 1020 suchthat subsequent fluid delivery injects the fluid through the passage(s)1039 of the sealing member 1038 into the interior of the balloon 1050,thereby inflating the balloon 1050. After the balloon 1050 has beeninflated, e.g., to remove material, dilate an obstruction, and/orotherwise treat a body lumen, the fluid may be evacuated from theinterior 1056 through the passage(s) 1039 and the lumen 1026.Alternatively, the inner member 1030 may be directed towards the firstposition to disengage the sealing member 1038 and open the outlet 1026.The fluid within the balloon 1050 may then be free to escape through thepassage(s) 1039 into the body lumen and deflate the balloon 1050.

Optionally, if desired, the inner member 1030 may be positioned at anintermediate position, i.e., between the first and second positions, inwhich fluid delivered from the outlet 1026 may be divided such that somefluid enters the passage(s) 1039 and expands the balloon 1050 while theremaining fluid is delivered into the body lumen. The relative amount ofinflation and fluid delivery into the body lumen may be adjusted, asdesired, simply by directing the inner member 1030 proximally ordistally to move the sealing member 1038 closer to or further from theoutlet 1027. This procedure may be accomplished using external imaging,e.g., if the fluid includes radiopaque contrast, to monitor theinflation and/or position of the balloon 1050 and/or the surroundingvasculature within which the balloon 1050 is located.

In another option, the apparatus 1010 may be used to deliver andaspirate fluid using the outlet 1027. For example, a user may want todeliver and remove one or more diagnostic and/or therapeutic agentswithin a body lumen using the apparatus 1010. In one example, contrast,dyes, or other material for facilitating imaging may be delivered intothe body lumen from the outlet 1027 (with the inner member 1030 andsealing member 1038 in the distal position) and then aspirated back intothe outlet 1027 to reduce the amount of contrast that remains within thebody lumen or travels to other locations in the patient's body.

In another example, a lytic agent may be delivered into the body lumen,e.g., to break up clot or other material within the body lumen, and thenloose material may then be aspirated into the outlet 1027 and throughthe lumen 1026, which may reduce the risk of bleeding or otherwiseexposing the lytic agent systemically to the patient's body. The outlet1027 may also be used to aspirate pieces of thrombus or other materialthat is not dissolved or broken down by the agent and/or is otherwiseloosened within the body lumen. During such procedures, the balloon 1050may be at least partially inflated, e.g., by directing the inner member1030 to an intermediate position, to stop or reduce flow through thebody lumen while the one or more agents are delivered and aspirated,which may also reduce exposure of other locations to the agent(s)delivered into the body lumen.

Turning to FIG. 38, an alternative embodiment of the apparatus 1010′ isshown similar to the apparatus 1010 of FIGS. 36-37C. The apparatus 1010′includes an outer member 1020,′ an inner member 1030,′ a balloon 1050,′and a sealing member 1038′ similar to the apparatus 1010. The apparatus1010′ may be operable in first and second modes by directing the innermember 1030′ between a first or distal position and a second or proximalposition, also similar to the apparatus 1010.

In addition, however, the apparatus 1010′ includes a spring or otherbiasing mechanism 1090′ coupled between the inner and outer members1030,′ 1020′ for biasing the inner member 1030′ to one of the first andsecond positions. For example, as shown, the spring 1090′ may bias theinner member 1030′ to the proximal position, i.e., such that the outlet1027′ of the apparatus 1010′ is normally closed and/or enhancing seatingof the sealing member 1038′ into the outlet 1027.′ The bias may beovercome by directing the inner member 1030′ distally to unseat thesealing member 1038′ and open the outlet 1027.′

As shown, the spring 1090′ includes a first end 1092′ attached orotherwise coupled to the distal end 1024′ of the outer member 1020,′ anda second end 1094′ attached or otherwise coupled to the distal end 1034′of the inner member 1030′ and/or the sealing member 1038.′ As shown, thesecond end 1094′ of the spring 1090′ may be attached between the sealingmember 1038′ and the inner member 1030′ or otherwise to the sealingmember 1038,′ while still accommodating the passage 1039′ extendingthrough the sealing member 1038.′ In exemplary embodiments, the ends1092,′ 1094′ of the spring 1090′ may be attached to the inner and outermembers 1030,′ 1020′ by bonding with adhesive, sonic welding, fusing,interference fit, one or more connectors (not shown), and the like.

The relative diameter of the spring 1090′ and the inner member 1030′ maybe set to reduce the risk of over-extension of the spring 1090.′ Forexample, the spring 1090′ may be relaxed or under slight tension whenthe inner member 1030′ is in the proximal position and may be placedunder higher tension when the inner member 1030′ is directed distally.As the spring 1090′ is placed under higher tension, the diameter of thespring 1090′ may decrease thereby increasing friction between the spring1090′ and the inner member 1030.′ This increasing friction may reducethe risk of over-extending the spring 1090,′ which may otherwiseplastically deform the spring 1090′ or otherwise prevent the spring1090′ from biasing the inner member 1030′ proximally towards theproximal position.

Turning to FIG. 39, yet another alternative embodiment of the apparatus1010″ is shown similar to the apparatus 1010′ of FIG. 38. The apparatus1010″ includes an outer member 1020,″ an inner member 1030,″ a balloon1050,″ a sealing member 1038,″ and a spring 1090,″ similar to theapparatus 1010.′ The apparatus 1010″ may be operable in first and secondmodes by directing the inner member 1030″ between a first or distalposition and a second or proximal position, also similar to theapparatus 1010, 1010.′

In addition, the apparatus 1010″ includes a helical member 1070″ withinthe balloon 1050″ that may be expanded to an expanded helical shape,similar to other embodiments herein. For example, the helical member1070″ may include a first or proximal end coupled to the outer member1020′″ (not shown) and a second or distal end 1074″ coupled to the innermember 1030,″ adjacent the distal end 1054″ of the balloon 1050.″ Thus,the apparatus 1010″ may also be operated in a third mode, e.g., bydirecting the inner member 1030″ proximally from the second position toa third position in which the helical member 1070″ is axially compressedand radially expanded. The balloon 1050″ may remain collapsed while thehelical member 1070″ is expanded or may be inflated and then collapsedafter the helical member 1070″ is expanded, similar to other embodimentsherein.

After the helical member 1070″ and balloon 1050″ are used to removematerial in the expanded helical shape, the inner member 1030″ may bedirected distally to return the helical member 1070″ to its originalcontracted shape around the inner member 1030.″ This action may extendthe spring 1090″ and open the outlet 1027.″ However, as discussed above,the relative sizes of the spring 1090″ and the inner member 1030″ may besuch that the spring 1090″ compresses as it extends and frictionallyengages the inner member 1030,″ thereby reducing the risk of the spring1090″ over-extending while the inner member 1030″ is directed distally.

It will be appreciated that elements or components shown with anyembodiment herein are exemplary for the specific embodiment and may beused on or in combination with other embodiments disclosed herein.

While the invention is susceptible to various modifications, andalternative forms, specific examples thereof have been shown in thedrawings and are herein described in detail. It should be understood,however, that the invention is not to be limited to the particular formsor methods disclosed, but to the contrary, the invention is to cover allmodifications, equivalents and alternatives falling within the scope ofthe appended claims.

1. An apparatus for treating a body lumen, comprising: an outer memberincluding a proximal end, a distal end sized for introduction into abody lumen, and a first lumen extending between the proximal and distalends; an expandable balloon comprising a proximal end secured to theouter member distal end, and a distal end comprising an outlet, theballoon comprising an interior communicating with the first lumen andthe balloon outlet; an inner member slidably disposed within the firstlumen, the inner member comprising a proximal end adjacent the outermember proximal end, and a distal end extending from the balloon outlet;a sealing member on the inner member distal end, the inner member beingmovable between a first position wherein the sealing member is spacedfrom the balloon outlet such that fluid introduced through the firstlumen passes through the balloon interior and out the balloon outlet,and a second position wherein the sealing member substantially seals theballoon outlet such that fluid introduced through the first lumen entersthe balloon interior to expand the balloon; and a spring element betweena spring stop in the balloon distal end and the inner member distal endfor biasing the inner member towards the second position.
 2. Theapparatus of claim 1, further comprising a handle on the outer memberproximal end, and an actuator on the handle for directing the innermember from the second position to the first position to open theballoon outlet.
 3. The apparatus of claim 2, wherein the spring elementis biased to automatically direct the inner member from the firstposition to the second position when the actuator is released.
 4. Theapparatus of claim 2, wherein the actuator is configured to overcome thebias of the spring element to direct the inner member from the secondposition to the first position. 5-8. (canceled)
 9. The apparatus ofclaim 1, wherein the sealing member comprises a tapered proximal end,and wherein the balloon comprises a distal tip extending distally fromthe balloon distal end, the distal tip biased to flare outwardly awayfrom the balloon for receiving the tapered proximal end of the sealingmember therein.
 10. The apparatus of claim 1, wherein the sealing membercomprises a tapered proximal end, and wherein the balloon comprises adistal tip extending distally from the balloon distal end, the distaltip comprising flexible material such that the distal tip resilientlyexpands for receiving the tapered proximal end of the sealing membertherein in the second position.
 11. (canceled)
 12. The apparatus ofclaim 1, wherein the inner member comprises a curved distal tipextending distally from the inner member distal end beyond the sealingmember, the distal tip being resiliently flexible such that the distaltip is substantially straightened when an elongate member is introducedthrough the inner member and the distal tip, the distal tip resilientlyreturning towards its curved shape when the elongate member is removedfrom the distal tip.
 13. The apparatus of claim 1, further comprising acoating on an inner surface of at least a portion of the balloon distalend to reduce friction between the balloon distal end and the sealingmember in the second position.
 14. The apparatus of claim 1, wherein thesealing member comprises a nosecone extending from the inner memberdistal end, the nosecone having a beveled distal tip.
 15. An apparatusfor treating a body lumen, comprising: an outer member including aproximal end, a distal end sized for introduction into a body lumen, anda first lumen extending between the proximal and distal ends; anexpandable balloon comprising a proximal end secured to the outer memberdistal end, and a distal end comprising an outlet, the ballooncomprising an interior communicating with the first lumen and theballoon outlet; an inner member slidably disposed within the firstlumen, the inner member comprising a proximal end adjacent the outermember proximal end, and a distal end extending from the balloon outlet;a sealing member on the inner member distal end, the inner member beingmovable between a first position wherein the sealing member is spacedfrom the balloon outlet such that fluid introduced through the firstlumen passes through the balloon interior and out the balloon outlet,and a second position wherein the sealing member substantially seals theballoon outlet such that fluid introduced through the first lumen entersthe balloon interior to expand the balloon; a spring element comprisingan intermediate portion fixed to the inner member within the balloon, aproximal portion extending proximally from the intermediate portion, anda distal portion extending distally from the intermediate portion, thedistal portion coupled to the balloon distal end, thereby biasing theinner member towards the second position; and a helical membercomprising a first end coupled to the outer member distal end and asecond end coupled to the proximal portion of the spring element, thehelical member extending helically around the inner member within theballoon interior, the inner member movable to a third position in whichthe inner member distal end is directed towards the outer member distalend to cause the helical member to expand radially outwardly, theballoon overlying the helical member to define an expanded helicalshape. 16-22. (canceled)
 23. The apparatus of claim 15, wherein theproximal portion of the spring element has a relatively low springconstant such that the proximal portion of the spring element extendswhen the inner member is directed to the first position to providecompliance to the helical member.
 24. The apparatus of claim 23, whereinthe proximal portion of the spring element has a lower spring constantthan the distal portion of the spring element.
 25. The apparatus ofclaim 15, wherein the balloon distal end comprises a spring stoptherein, and wherein the distal portion of the spring element contactsthe spring stop to bias the inner member towards the second position.26. The apparatus of claim 15, further comprising a collar slidablydisposed on the inner member, the proximal portion of the spring elementcoupled to the collar and the second end of the helical member coupledto the collar, thereby coupling the second end to the proximal portionof the spring element. 27-33. (canceled)
 34. The apparatus of claim 15,further comprising a handle on the outer member proximal end, and anactuator on the handle for directing the inner member between the secondposition to the first position to open the balloon outlet, and fordirecting the inner member to the third position to expand the helicalmember.
 35. The apparatus of claim 34, wherein the spring element isbiased to automatically direct the inner member from the first positionto the second position when the actuator is released.
 36. (canceled) 37.The apparatus of claim 34, wherein the inner member comprises a secondlumen extending between the inner member proximal and distal ends forreceiving an elongate member therethrough, and wherein the handlecomprises a retainer on an exterior surface of the handle for securing aportion of an elongate member received in the second lumen.
 38. Anapparatus for treating a body lumen, comprising: an elongate outermember including a proximal end comprising a handle, a distal end sizedfor introduction into a body lumen, and a first lumen extending betweenthe proximal and distal ends; an expandable balloon comprising aproximal end secured to the outer member distal end, and a distal endcomprising an outlet, the balloon comprising an interior communicatingwith the first lumen and the balloon outlet; an inner member slidablydisposed within the first lumen, the inner member comprising a proximalend adjacent the outer member proximal end, a distal end extending fromthe balloon outlet, and a sealing member on the inner member distal end;a first actuator on the handle coupled to the inner member for movingthe inner member between a first position wherein the sealing member isspaced from the balloon outlet such that fluid introduced through thefirst lumen passes through the balloon interior and out the balloonoutlet, and a second position wherein the sealing member substantiallyseals the balloon outlet such that fluid introduced through the firstlumen enters the balloon interior to expand the balloon; a helicalmember comprising a distal end coupled to the inner member distal endand a proximal end disposed proximal to the distal end, the helicalmember extending helically around the inner member within the ballooninterior; and a second actuator on the handle coupled to the proximalend of the helical member for moving the helical member proximal enddistally to cause the helical member to compress axially and expandradially outwardly.
 39. The apparatus of claim 38, further comprising aspring element disposed at least partially within the balloon interiorfor biasing the inner member towards the second position.
 40. Theapparatus of claim 38, further comprising a source of inflation mediafor expanding the balloon before activating the second actuator toexpand the helical member such that the helical member expandssubstantially unimpeded within the balloon interior. 41-42. (canceled)43. The apparatus of claim 38, further comprising a spring elementincluding an intermediate portion fixed to the inner member within theballoon interior, a proximal portion extending proximally from theintermediate portion and coupled to the helical member distal end, and adistal portion extending distally from the intermediate portion, thedistal portion coupled to the balloon distal end, thereby biasing theinner member towards the second position. 44-47. (canceled)
 48. Anapparatus for treating a body lumen, comprising: an elongate outermember including a proximal end, a distal end sized for introductioninto a body lumen, and a first lumen extending between the proximal endand an outlet in the distal end; an inner member slidably disposedwithin the first lumen and having a cross-section smaller than the firstlumen such that an annular lumen is defined between the outer and innermembers between the outer member proximal end and the outlet, the innermember comprising a proximal end adjacent the outer member proximal end,and a distal end adjacent the outer member distal end; an expandableballoon comprising a proximal end secured to the outer member distal endand a distal end secured to the outer member distal end distal to theproximal end, the balloon comprising an interior communicating with thefirst lumen via one or more openings in the outer member distal end; asealing member on the inner member distal end, the inner member beingmovable between a first position wherein the sealing member is spacedfrom the outlet such that fluid introduced through the first lumen exitsthe outlet, and a second position wherein the sealing membersubstantially seals the outlet such that fluid introduced through thefirst lumen enters the balloon interior to expand the balloon; and aspring element between a spring stop in the balloon distal end and theinner member distal end for biasing the inner member towards the secondposition. 49-60. (canceled)
 61. A method for treating a body lumen of apatient using a balloon apparatus comprising an outer member including afirst lumen extending between proximal and distal ends thereof, an innermember slidable within the first lumen, and a balloon comprising aproximal end attached to the outer member distal end, a distal endincluding an outlet and an interior communicating with the first lumenand the outlet, the method comprising: introducing the distal end of theouter member into a body lumen with the balloon in a contractedcondition and the inner member in a proximal position such that theoutlet is substantially sealed by a sealing member on the inner memberdistal end; directing an actuator on a proximal end of the apparatus tomove the inner member to a distal position consequently directing thesealing member distally to open the outlet; delivering fluid through thefirst lumen such that the fluid passes through the balloon interior andexits the open outlet into the body lumen; directing the inner membertowards the proximal position to substantially seal the outlet with thesealing member, the spring element biasing the inner member to enhancethe sealing member sealing the outlet; and delivering fluid through thefirst lumen with the outlet substantially sealed, thereby expanding theballoon from the contracted condition to an enlarged condition. 62-70.(canceled)
 71. A method for treating a body lumen of a patient using aballoon apparatus comprising an outer member including a first lumenextending between proximal and distal ends thereof, an inner memberslidable within the first lumen, and a balloon comprising a proximal endattached to the outer member distal end, a distal end including anoutlet and an interior communicating with the first lumen and theoutlet, the method comprising: introducing the distal end of the outermember into a body lumen with the balloon in a contracted condition;delivering fluid through the first lumen with the outlet sealed, therebyexpanding the balloon from the contracted condition to an expandedcondition; expanding a helical member within the balloon interior withthe balloon in the enlarged condition; collapsing the balloon around theexpanded helical member such that the balloon conforms substantially tothe shape of the helical member to define an expanded helical shape; anddirecting the balloon along a wall of the body lumen in the expandedhelical shape to remove material from the wall of the body lumen. 72-74.(canceled)
 75. A method for treating a body lumen of a patient using anapparatus comprising an outer tubular member comprising a first lumenextending between proximal and distal ends thereof, and a ballooncomprising a proximal end attached to the outer member distal end, adistal end including an outlet and an interior communicating with thefirst lumen and the outlet, the method comprising: introducing a distalend of an elongate member into a patient's body until the distal end isdisposed within a body lumen, the elongate member comprising a sealingmember on the distal end; advancing the distal end of the outer memberover the elongate member with the balloon in a contracted conditionuntil the balloon outlet is disposed adjacent the sealing member;coupling an actuator on the outer member proximal end to the innermember; directing the actuator to a first position wherein the sealingmember substantially seals the outlet; delivering fluid into the firstlumen with the outlet substantially sealed, thereby expanding theballoon to an enlarged condition; directing the actuator to a secondposition wherein the sealing member is spaced from the outlet; anddelivering fluid into the first lumen with the sealing member spacedfrom the outlet, thereby delivering the fluid from the outlet into thebody lumen. 76-77. (canceled)
 78. A method for treating a body lumen ofa patient using an apparatus comprising an outer tubular membercomprising a first lumen extending between proximal and distal endsthereof, a balloon comprising a proximal end attached to the outermember distal end, a distal end including an outlet and an interiorcommunicating with the first lumen and the outlet, and a helical memberwithin the balloon interior, the method comprising: introducing a distalend of an elongate member into a patient's body until the distal end isdisposed within a body lumen, the elongate member comprising an enlargedmember on the distal end; advancing the distal end of the outer memberover the elongate member with the balloon in a contracted conditionuntil the balloon outlet is disposed adjacent the sealing member;directing at least one of the outer member and the inner member axiallyrelative to the other to compress the balloon axially and expand ahelical member within the balloon interior, the balloon conformingsubstantially to the shape of the helical member as the helical memberis expanded to define an expanded helical shape; and directing theballoon along a wall of the body lumen in the expanded helical shape toremove material from the wall of the body lumen. 79-81. (canceled) 82.An apparatus for treating a body lumen, comprising: an outer memberincluding a proximal end, a distal end sized for introduction into abody lumen, and a first lumen extending between the proximal end and anoutlet in the distal end; an inner member slidably disposed within thefirst lumen, the inner member comprising a proximal end adjacent theouter member proximal end, and a distal end extending distally beyondthe outer member distal end; a sealing member on the inner member distalend comprising one or more passages therethrough; and an expandableballoon comprising a distal end secured to the inner member distal enddistally beyond the sealing member, and a proximal end secured to thesealing member such that an interior of the balloon communicates withthe one or more passages; the inner member being movable between a firstposition wherein the sealing member is spaced from the outlet of theouter member such that fluid introduced through the first lumen passesthrough the outlet into a region around the apparatus, and a secondposition wherein the sealing member substantially seals the outlet suchthat fluid introduced through the first lumen passes through the one ormore passages and enters the balloon interior to expand the balloon. 83.The apparatus of claim 82, further comprising a spring element coupledbetween the inner member and the outer member for biasing the innermember towards the second position. 84-87. (canceled)
 88. A method fortreating a body lumen of a patient using a balloon apparatus comprisingan outer member including a first lumen extending between proximal anddistal ends thereof, an inner member slidable within the first lumen, aballoon attached to a distal end of the inner member beyond the outermember distal end, the method comprising: introducing the distal end ofthe outer member into a body lumen with the balloon in a contractedcondition and the inner member in a proximal position such that asealing member on the inner member substantially seals an outlet in theouter member distal end communicating with the first lumen; directing anactuator on a proximal end of the apparatus to move the inner member toa distal position consequently directing the sealing member away fromthe outlet; delivering fluid through the first lumen such that the fluidpasses through the outlet into the body lumen; directing the innermember towards the proximal position to substantially seal the outletwith the sealing member such that one or more passages in the sealingmember communicate between the first lumen and an interior of theballoon; and delivering fluid through the first lumen with the outletsubstantially sealed, thereby delivering fluid through the one or morepassages into the balloon interior to expand the balloon from thecontracted condition to an enlarged condition. 89-90. (canceled)